MAUDE Adverse Event Report: Stryker Leibinger Freiburg ORTHOLOCK, COUPLING FOR ORTHOPEDIC ANCHORING SYSTEM; Neurological stereotaxic Instrument

Catalog Number	6007-003-000
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during femoral impaction, the ortholock became loose, resulting in loss of navigation functionality.Consequently, the procedure was completed using conventional manual instrumentation.Due to reduced navigational accuracy following device instability, bone cement was utilized to complete the procedure.No adverse patient outcome was reported.

• Brand Name: ORTHOLOCK, COUPLING FOR ORTHOPEDIC ANCHORING SYSTEM
• Common Device Name: Neurological stereotaxic Instrument
• 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 weber ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; +49()7614888208
• MDR Report Key: 50882151
• Report Number: 0008010177-2026-00181
• Device Sequence Number: 13427920
• Product Code: HAW
• UDI-Device Identifier: 04546540442895
• UDI-Public: 04546540442895
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 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: Health Professional
• Device Catalogue Number: 6007-003-000
• Device Lot Number: B/09/2023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown