MAUDE Adverse Event Report: Stryker Leibinger Freiburg SCR,UNIII AXS, SD,1.5X5MM; FASTENER, PLATE, CRANIOPLASTY

Catalog Number	56-15935
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Hematoma (1884); Dysphasia (2195)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during cranial closure following tumor removal, a screwdriver slipped through a burr hole cover while reinserting a self drilling screw, resulting in intracranial bleeding.The bone flap was removed to identify and manage the source of bleeding.The patient developed a brain hematoma, underwent ct mri imaging, was admitted to the icu, and the original bone flap was lost.

• Brand Name: SCR,UNIII AXS, SD,1.5X5MM
• Common Device Name: FASTENER, PLATE, CRANIOPLASTY
• 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 ; +49()7614888208
• MDR Report Key: 50081497
• Report Number: 0008010177-2026-00124
• Device Sequence Number: 10219171
• Product Code: HBW
• UDI-Device Identifier: 37613327090742
• UDI-Public: 37613327090742
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K151387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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: 56-15935
• Device Lot Number: unknown
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 07/30/2026
• 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