MAUDE Adverse Event Report: STRYKER GMBH SPRING PLATE, 2-HOLE PRO; PLATE, FIXATION, BONE

Catalog Number	425985S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device(s) were not returned for evaluation, and no other additional information was received from the clinical site.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
Event or Problem Description
The manufacturer received a stryker collaborative study (scs) named "a post-market clinical evaluation of the treatment of pelvis fractures with the pelvis next generation plates of the pro implants system" that contains collected data on the usage and the outcomes of pro pelvis next generation implants.Retrospective analysis was conducted using the clinic documents and radiographic images of cases at uab from january 2024- december 2024 during the review of the report, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available; however, the following adverse event was reported: patient 15 was diagnosed with femoral head necrosis at 45 days post-operatively.This adverse event was categorized as severe but did not require revision surgery at the time of reporting.The event was determined to be possibly related to both the device and the procedure and remains ongoing.This patient is scheduled for a tha in the near future.

• Brand Name: SPRING PLATE, 2-HOLE PRO
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22019651
• Report Number: 0008031020-2025-00895
• Device Sequence Number: 13132729
• Product Code: HRS
• UDI-Device Identifier: 07613327544015
• UDI-Public: 07613327544015
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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: 425985S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown