MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK CUSTOMIZED CRANIAL IMPLANT, L

Catalog Number	78-40030
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported that there was a discrepancy between the implant and the cranial shape, this implant was not used.An alternative implant was used.The surgery was delayed for an hour.
Additional Manufacturer Narrative
The reported event could not be confirmed, because the information provided was not sufficient.The provided information was not sufficient to determine the complaint root cause.The swollen brain might be the reason for the reported implant fitting issue.However, this could not be confirmed, because no postoperative ct scan was provided.Should a postoperative ct scan be provided in the future, this complaint will be re-opened.Based on the investigation, the dhr review including a 100% control of implant dimensions as well as the assessment of the responsible principal engineer r&d, no indication for any design, material or manufacturing related problems were found in this investigation.Therefore no corrective and/or preventive actions are deemed necessary at this time.
Event or Problem Description
It was reported that there was a discrepancy between the implant and the cranial shape, this implant was not used.An alternative implant was used.The surgery was delayed for an hour.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT, L
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7846170
• Report Number: 0008010177-2018-00085
• Device Sequence Number: 1981082
• Product Code: GWO
• UDI-Device Identifier: 07613327129298
• UDI-Public: 07613327129298
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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: 78-40030
• Device Lot Number: 1803081006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR