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	10/03/2024
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 should have covered the whole entire temporal bone section and had to be cut in half to make it fit during surgery.
Additional Manufacturer Narrative
Additional information: h6.Correction: b5.Post op ct scans or pictures from the issue were not provided for investigation, thus, the reported event could not be confirmed.The implant was successfully implanted without surgical delay or the need for additional equipment, though the sales representative could not provide photos of the reported issue but indicated the area of concern in a design image.Analysis confirmed the implant met design specifications and quality standards, with no discrepancies found in manufacturing or inspection records.Based on the investigation steps performed, there is no indication of 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.
Event or Problem Description
It was reported that the implant should have covered the whole entire temporal bone section but has been implanted successfully.It turned out that the previously made statement (device needed to be cut in half) has belonged to another case and was therefore evaluated in another investigation.

• 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: 20558806
• Report Number: 0008010177-2024-00119
• Device Sequence Number: 19633522
• Product Code: GWO
• UDI-Device Identifier: 07613327129274
• UDI-Public: 07613327129274
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 06/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 78-50040
• Device Lot Number: 2409301015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 06/03/2025
• 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: Other
• Patient Sex: Unknown