A device malfunctioned, an implant failed, or someone was hurt. We determine what happened from the physical and clinical evidence — independently, and to a standard that holds up in court.
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Medical device and implant failures sit at the intersection of engineering and biology, and that intersection is where most investigations go wrong. A catheter that fractures inside a vessel, a hip stem that fails at the modular taper, an infusion pump that under-delivers because of a firmware race condition — each leaves a distinct physical signature, but reading it requires knowing what the device was supposed to do, what a normal tissue response looks like versus a failing one, and which standard the manufacturer was actually held to. This department covers the failure modes across active devices, implants, orthopedic hardware, tubing and catheters, and the biomechanics of injury causation itself.
Each specialization area covers a distinct device category or injury mechanism with its own physics, examination protocol, and governing standards. Start with the one that matches your incident.
Infusion pumps, ventilators, monitors, and active implantables — firmware, sensor, and mechanical malfunction.
investigateBreast implants, hernia mesh, cardiac leads, and other soft-tissue implantables — rupture, migration, and corrosion.
investigateInjury causation analysis — occupant kinematics, fall biomechanics, and traumatic injury mechanisms.
investigatePlates, screws, rods, and joint replacement hardware — fatigue fracture, loosening, and taper corrosion.
investigateIV catheters, central lines, and tubing sets — fracture, connector misconnection, kinking, and material degradation.
investigateThese investigations combine engineering analysis with clinical and regulatory evidence that other failure-analysis work rarely touches.
Technical briefings and case analyses on medical device, implant, and injury biomechanics failures — written by the people who investigate them.
Trauma fixation hardware has a finite fatigue life and is meant to be relieved of load by healing bone. When it breaks, the fracture surface usually says more about union than about metal.
readA plate that meets every applicable standard can still be part of a construct that fails. Working length, screw placement, junctions and mixed metals are assembly properties, not device properties.
readMost of what an explanted implant could prove is decided in theater, not in the laboratory. Cleaning, fixation and sterilization remove the surface record before anyone identifies it as evidence.
readPlasticizer migration, drug and lipid interaction, disinfectants and sterilization can leave a set unfit long before its labeled shelf life ends — and the device is usually cut, flushed or discarded first.
readReconstructing body kinematics from interior marks, restraint evidence and recorded data constrains what loading a body saw. A finding of inconsistency is strong; a finding of consistency excludes very little.
readA biomechanist establishes loading direction, magnitude and rate, and compares it against tolerance data. Diagnosis, timeline and baseline belong to medicine. Most challenges live on that boundary.
readIt carries a regulatory and biological layer that most product investigations do not. A device's failure has to be understood against the FDA submission pathway it went through, its adverse-event history in the MAUDE database, and its design history file — and, for anything implanted or used in a patient, against the clinical record and, often, pathology findings from the treating team. The physical evidence still matters most, but it is read alongside a much larger evidentiary record than a typical mechanical or electrical failure.
That is usually the single biggest risk to the investigation. Explanted implants and returned devices are frequently cleaned, discarded, or handled through routine hospital or biomedical-engineering processes that destroy the surface evidence — wear patterns, corrosion products, fracture surfaces — before anyone realizes a forensic question exists. Coordinating a retrieval and chain-of-custody protocol as early as possible, ideally before the explant procedure, materially changes what can later be proven.
By comparing the as-found condition of the device against its design specification and manufacturing records, and separately comparing the reported use against the labeled instructions for use and usability engineering file. A defect signature is intrinsic to the device — a material out of specification, a firmware logic error, a manufacturing deviation. A use-related or clinical cause tends to correlate with technique, patient anatomy, or placement documented in the medical record. The two are frequently confused from the outside and rarely confused once the underlying records are reviewed.
It depends on the device. The FDA governs premarket clearance and approval (510(k) and PMA pathways) and adverse-event reporting through MAUDE; the EU applies the Medical Device Regulation. Quality-system work references ISO 13485, risk management references ISO 14971, biocompatibility references ISO 10993, and electrical medical devices reference the IEC 60601 series. Implant-specific work adds material and mechanical standards such as the ASTM F-series and ISO 7206.
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