MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MEDPOR PRIORITY CUSTOMIZED - PLUS - XL; IMPLANT

Catalog Number	5444-5-410
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	10/18/2023
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.H3 other text : not available.
Event or Problem Description
It was reported by the sales representative that the implant was not manufactured correctly.The implant was built up too far posterior and the surgeon noted it was not possible to complete the surgery using the implant.There was an alternative option to complete the surgery successfully.No significant surgery delay was reported and no adverse events were reported.
Additional Manufacturer Narrative
The implant exhibited a greater prominence compared to the natural skull.This resulted from the necessity of seamlessly integrating the implant into a slightly asymmetrical skull.Summarizing all obtained information, the asymmetrical skull of the patient caused the design team to design an implant with more projection.The additional projection and the plus feature ordered did not allow the surgeon to close the skin flap as planned.Based on the performed investigation, there is no indication for an incorrectly working a product or design, material or manufacturing related issue.H3 other text : not available.
Event or Problem Description
It was reported by the sales representative that the implant was not manufactured correctly.The implant was built up too far posterior and the surgeon noted it was not possible to complete the surgery using the implant.There was an alternative option to complete the surgery successfully.No significant surgery delay was reported and no adverse events were reported.

• Brand Name: MEDPOR PRIORITY CUSTOMIZED - PLUS - 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: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 18140170
• Report Number: 0008010177-2023-00072
• Device Sequence Number: 17789191
• Product Code: FWP
• UDI-Device Identifier: 07613327465570
• UDI-Public: 07613327465570
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K191916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 5444-5-410
• Device Lot Number: 2309291020 (B)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown