MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG SCR/2.0X14MM ST BONE CRS PIN CF; IMPLANT

Catalog Number	92-50214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that healing of the sagittal split failed a second time; therefore, reconstruction plates were placed after removal of the positional screws.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.
Additional Manufacturer Narrative
Additional information: h6.The patient developed a non-union after a double jaw procedure with sagittal split on (b)(6) 2025, requiring repeat surgeries on (b)(6) 2025, and (b)(6) 2025, the latter involving removal of positional screws and placement of reconstruction plates.A stryker medical expert reviewed the case and concluded that the device did not cause the non-union (see communication log).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.
Event or Problem Description
No new information.

• Brand Name: SCR/2.0X14MM ST BONE CRS PIN CF
• Common Device Name: IMPLANT
• 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 drewenskus ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 23437910
• Report Number: 0008010177-2025-00148
• Device Sequence Number: 20970502
• Product Code: JEY
• UDI-Device Identifier: 37613327419338
• UDI-Public: 37613327419338
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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: 92-50214
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 02/06/2026
• 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