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

Model Number	78-50030
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
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 not available for return.
Event or Problem Description
It was reported that the implant did not fit as expected so the surgeon shaved off 2-3mm of the implant and it did not fit still.The surgery was completed successfully using another product.No other information is known at this time.
Additional Manufacturer Narrative
The post-op scan provided by the sales representative was examined in the complaint analysis performed by the peek customized cranial implant design team.From the post-op scan it could be seen that the bone fragments and calcifications were not fully removed during surgery as indicated and advised in the design proposal.Fragments in the frontal area of the patient¿s skull were still existent.An overlay of the post-op scan and pre-op scan was performed which additionally showed that fragments still existed that were supposed to be removed.The existence of the bone fragments is identified to be the root cause for the implant seeming ¿too large¿ and ¿a lot thicker than the native skull".A review of the request details in erequest for lot code # 2012211010 showed that the peek implant was requested as a priority case and designed off a ct scan uploaded on 2020-dec-28.The implant was sent on (b)(6) 2020.Based on the performed statistical investigation and review there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.In summary, the root cause of the reported event were bone fragments, that were not fully removed during surgery as indicated and advised in the design proposal.H3 other text : device is not available for return.
Event or Problem Description
It was reported that the implant did not fit as expected so the surgeon shaved off 2-3mm of the implant and it did not fit still.The surgery was completed successfully using another product.No other information is known at this time.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT PRIORITY, L
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 11590640
• Report Number: 0008010177-2021-00018
• Device Sequence Number: 11742227
• Product Code: GWO
• UDI-Device Identifier: 07613327129267
• UDI-Public: 07613327129267
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152076
• 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): 06/11/2021

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 Model Number: 78-50030
• Device Catalogue Number: 78-50030
• Device Lot Number: 2012211010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other