MAUDE Adverse Event Report: STRYKER GMBH CURVED PLATE, 4 HOLES; PLATE, FIXATION, BONE

Model Number	40-15011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Reaction (2414)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Variax foot plate metallosis noticed upon removal on (b)(6) 2019 by surgeon.Implanted on (b)(6) 2019.Removal not for non-union, just removal of metalware.
Additional Manufacturer Narrative
Correction: refer to d10/h3 the reported event could be confirmed.A picture of the affected foot was provided.Indeed, black deposits were noticed on the soft tissues especially on the distal part.The l plate as the screws that were implanted with it were returned after decontamination, and do not present any deformation, breakage or such.No deposits can be noticed anymore, since it was decontaminated.The curved plate and its screws were not returned for investigation.In this case, the expertise of a medical expert was requested.They stated the following; "[.] the literature talks about the varying corrosive effects of anodized titanium, relating to the thickness and color of the anodized layers.At a fracture site, wolff¿s law is occurring with a generation of an electrical current, although very slight, the current occurs within the solutions around the plate and soft-tissue and will corrode to the metal surface.It is the interaction of an inorganic material in titanium plates, and soft tissue and he degree of roughness of the implant surface, the methods utilized in achieving the surface topography, and the chemistry of implant materials (titanium), are some of the factors that may affect the soft tissue response of the plate to the adjacent soft tissue and create the grayish color.There has been no risk reported with this corrosive action since the levels of local metal ions and systemic ions is usually at very low levels in these cases.In case of high levels of metal ions, risks have been reported associated with local soft tissue damage, delayed hypersensitivity reaction (type iv) and systemic toxicity.[.]" this case can thus be classified as patient factors related.It can be explained by how the patient reacted to the device.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.H3 other text : device disposition is unknown.
Event or Problem Description
Variax foot plate metalosis noticed upon removal on 3-dec-19 by surgeon.Implanted on 5-jun-19.Removal not for non-union, just removal of metalware.

• Brand Name: CURVED PLATE, 4 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9549256
• Report Number: 0008031020-2020-00056
• Device Sequence Number: 16705582
• Product Code: HRS
• UDI-Device Identifier: 07613154627783
• UDI-Public: 07613154627783
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K063875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 40-15011
• Device Catalogue Number: 40-15011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR