MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG SCR/2.0X12MM ST BONE CRS PIN CF; PLATE, BONE

Catalog Number	92-50212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the screws were removed because they were too long and causing pain to the lingual nerve.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The reported event of screws being too long and causing pain on the lingual nerve could not be confirmed.The screws were removed on 11 may 2026; however, no imaging or additional information was available to confirm screw length, positioning, or involvement of the lingual nerve.Based on the investigation, there is no indication for an incorrectly working product or any design, material, or manufacturing related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.

• Brand Name: SCR/2.0X12MM ST BONE CRS PIN CF
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): Stryker Leibinger Freiburg; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: elena gehring ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; +49()7614888208
• MDR Report Key: 25318123
• Report Number: 0008010177-2026-00071
• Device Sequence Number: 10128462
• Product Code: JEY
• UDI-Device Identifier: 37613327419307
• UDI-Public: 37613327419307
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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
• Device Catalogue Number: 92-50212
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 09/16/2026
• 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: Required Intervention
• Patient Sex: Unknown