MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK CUSTOMIZED CRANIAL IMPLANT, XL

Catalog Number	78-40040
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
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 slight adjustment due to soft tissue interference.
Additional Manufacturer Narrative
Additional information: h6.Correction: it was determined after receiving further clarification from the customer and the log files from the device, this event for this product was not a reportable event per cfr 21, part 803.This supplemental is being filed to identify an mdr was not required for this event.The sales representative reported only positive feedback regarding the peek implants, with the surgeon highlighting the ease of use and intraoperative flexibility as key advantages during the peek study cases.According to the ifu (rev ac, 2023-mar-14), slight intraoperative modifications are anticipated and permitted due to possible anatomical changes, and such adjustments do not meet the definition of a complaint per stryker¿s quality guidelines.There is no indication for any design, material, or manufacturing-related issue or patient/user harm.
Event or Problem Description
No new information.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT, XL
• 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: 21908959
• Report Number: 0008010177-2025-00064
• Device Sequence Number: 18325127
• Product Code: GWO
• UDI-Device Identifier: 07613327129250
• UDI-Public: 07613327129250
• 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): 07/30/2025

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: 78-40040
• Device Lot Number: ID 2406121032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/30/2025
• 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