MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK PRIORITY CUST IMPL XLARGE; IMPLANT

Catalog Number	78-50040
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	01/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the surgery the custom implant did not fit as expected.
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 during the surgery the custom implant did not fit as expected.
Additional Manufacturer Narrative
Update: h6.Corrected: h1.The reported event (implant did not fit) could be confirmed based on the provided post op ct scan.After investigation conclusion is made, the peek implant was designed according and manufactured according to specification.No device problem could be found.Based on the analysis above, the assumption is that the implant was correctly designed and manufactured to fit the bony anatomy.However, the presence of brain swelling or soft tissue in the area during surgery could have led to the difficulty of inserting the implant correctly.

• Brand Name: PEEK PRIORITY CUST IMPL XLARGE
• 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: verena baumgartner-kis ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 21282611
• Report Number: 0008010177-2025-00014
• Device Sequence Number: 9339779
• Product Code: GWO
• UDI-Device Identifier: 07613327129274
• UDI-Public: 07613327129274
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/28/2025

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: 78-50040
• Device Lot Number: 2410221026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 05/28/2025
• 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