MAUDE Adverse Event Report: Stryker GmbH CURVED PLATE, 4 HOLES; Plate, Fixation, Bone

Catalog Number	40-15011
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported "the variax 2 plate was implanted on (b)(6) 2025 and fractured outside a medical facility.Subsequent removal and reosteosynthesis took place on (b)(6) 2026.".
Event or Problem Description
As reported "the variax 2 plate was implanted on (b)(6) 2025 and fractured outside a medical facility.Subsequent removal and reosteosynthesis took place on (b)(6) 2026.".
Additional Manufacturer Narrative
Please note the correction to d4 lot #.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: CURVED PLATE, 4 HOLES
• Common Device Name: Plate, Fixation, Bone
• Manufacturer (Section D): Stryker GmbH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): Stryker Leibinger Freiburg; boetzingerstr. 41; postfach; freiburg D-791 11; GM D-79111
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 24887035
• Report Number: 0008031020-2026-00562
• Device Sequence Number: 21306575
• Product Code: HRS
• UDI-Device Identifier: 07613154627783
• UDI-Public: 07613154627783
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2026

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: 40-15011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 05/07/2026; 08/26/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 05/29/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown