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 Known Impact Or Consequence To Patient (2692)
Date of Event	12/16/2019
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.Device is implanted in patient.
Event or Problem Description
It was reported by a company representative that the custom-made implant with the patient's 3d scan, lacks symmetry and has an unaesthetic appearance.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT, XL
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 9594293
• Report Number: 0008010177-2020-00007
• Device Sequence Number: 2396581
• Product Code: GWO
• UDI-Device Identifier: 07613327129250
• UDI-Public: 07613327129250
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2020

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: No Information
• Device Catalogue Number: 78-40040
• Device Lot Number: 1910031005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1