MAUDE Adverse Event Report: STRYKER GMBH DORSAL DR PLATE, WIDE, LEFT, X-LONG VARIAX2 DR L71MM; PLATE, FIXATION, BONE

Catalog Number	625101S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "during a conversation with the doctor, the sales rep heard that the plate of a patient who had surgery on (b)(6) 2025 has fractured.The doctor told that the bone defect was large and had not fused, so it was inevitable that the plate broke off.Because the fracture area had shortened as the plate broke off, rather than becoming more stable and the bone had started to fuse, so there were no plans to remove the broken plate for some time while the doctor is monitoring the patient's condition.".
Additional Manufacturer Narrative
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 for the reported lot did not indicate any abnormalities.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.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.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "during a conversation with the doctor, the sales rep heard that the plate of a patient who had surgery on (b)(6) 2025 has fractured.The doctor told that the bone defect was large and had not fused, so it was inevitable that the plate broke off.Because the fracture area had shortened as the plate broke off, rather than becoming more stable and the bone had started to fuse, so there were no plans to remove the broken plate for some time while the doctor is monitoring the patient's condition.".

• Brand Name: DORSAL DR PLATE, WIDE, LEFT, X-LONG VARIAX2 DR L71MM
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23491140
• Report Number: 0008031020-2025-02048
• Device Sequence Number: 8552466
• Product Code: HRS
• UDI-Device Identifier: 07613327344349
• UDI-Public: (01)07613327344349(17)08312028(10)1000536517
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K212581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 625101S
• Device Lot Number: 1000536517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2023
• 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: Male