MAUDE Adverse Event Report: STRYKER GMBH PLATE ANCHORAGE LISFRANC / LARGE - LEFT; PLATE, FIXATION, BONE

Catalog Number	PLP30201
Health Effect - Clinical Codes	Tissue Damage (2104); Reaction (2414)
Date of Event	05/03/2019
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
Surgeon reported that he removed a anchorage plate on (b)(6) 2019.On removal he noticed what appeared to darkened tissue around the plate and screw interface.
Event or Problem Description
Surgeon reported that he removed a anchorage plate on friday (b)(6)2019.On removal he noticed what appeared to darkened tissue around the plate and screw interface.
Additional Manufacturer Narrative
The reported event could not be confirmed.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A medical opinion was provided by internal medical expert: "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 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." [original statement] if any further information is provided, the investigation report will be updated.

• Brand Name: PLATE ANCHORAGE LISFRANC / LARGE - LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8675003
• Report Number: 0008031020-2019-00523
• Device Sequence Number: 11390725
• Product Code: HRS
• UDI-Device Identifier: 07613252260875
• UDI-Public: 07613252260875
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K083447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

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 Catalogue Number: PLP30201
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 09/20/2019
• 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: 46 YR