MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK CUSTOMZED PRIORITY PLS XL; IMPLANT

Catalog Number	78-80040
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	01/31/2025
Type of Reportable Event	Serious Injury
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 peek implant needed to be adjusted intraoperatively due to poor fitting, and a new peek implant is required for a revision.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional information: h6 corrected: h1.The reported issue (inadequate fit) was confirmed by providing images.The implant was designed and manufactured according to specifications.No defects were identified in the product itself.However, bone fragments not detected by the software may have compromised the fit.Despite adjustments during surgery and the request for a replacement implant, the patient recovered well with the second implant, so no corrective measures are required.Based on the investigation, there is no evidence of a malfunctioning product or any design, material, or manufacturing defects.Therefore, no corrective and/or preventive measures are currently considered necessary.

• Brand Name: PEEK CUSTOMZED PRIORITY PLS 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: verena baumgartner-kis ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 21478889
• Report Number: 0008010177-2025-00025
• Device Sequence Number: 4121155
• Product Code: GWO
• UDI-Device Identifier: 07613327300109
• UDI-Public: 07613327300109
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/08/2025

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: 78-80040
• Device Lot Number: 2410211024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 07/08/2025
• 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