MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK CUSTOMIZED-PLUS-S; IMPLANT

Catalog Number	78-70010
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
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
It was reported that the implant required moderate adjustment due to soft tissue interference.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional information: h4, h6.The reported event could not be confirmed as no images or ct-scans were provided.The surgeon reported soft tissue interference at the posterior orbit, necessitating bone and implant adjustments, and noted imprecise cutting due to unsterilized guides used through a sterile bag, though the surgery was completed successfully with additional fixation plates and no complaints about the implant design.An adverse event involving cranial nerve iii paralysis and facial paresthesias was documented but determined by the surgeon to be unrelated to the device or procedure, and the implant was confirmed to have been designed and manufactured according to specifications.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: PEEK CUSTOMIZED-PLUS-S
• 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: 21900203
• Report Number: 0008010177-2025-00059
• Device Sequence Number: 17158705
• Product Code: GWO
• UDI-Device Identifier: 07613327300079
• UDI-Public: 07613327300079
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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
• Device Catalogue Number: 78-70010
• Device Lot Number: 2407191046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2024
• 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