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

Model Number	78-50040
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	03/29/2022
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 it was noticed during a procedure, the peek cci was too large and needed to be cut down to fit appropriately.
Additional Manufacturer Narrative
The reported event could be confirmed as intraoperative images were provided showing the compromised fit of the implant in the temporal region and the inability to insert the implant into this region.The sales representative provided the following additional information: because the curvature of the implant was going inwards to meet with the void, the implant sat too proud.About where the implant started to curve in, it was cut.Little to no temporalis muscle was left at the time of surgery and the highlighted calcification was removed.The scan was ~6 months old at the time of implant order, but the latest scan available.An analysis of the implant design and all quality relevant steps was performed by the peek cci design team.It showed that all steps were performed in accordance to the applicable freqi procedures.The implant is designed as it got requested through erequest with a temporal pop out and the 10 mm temporal trim.In conclusion, the implant was designed as requested by the customer.The main contributing factor is assumed to be the age of the ct scan, and a misunderstanding of the design options for a peek implant.Both were pointed out to the sales representative.Overall, the implant was designed according to all quality instructions, and manufactured to specification.
Event or Problem Description
It was reported that it was noticed during a procedure, the peek cci was too large and needed to be cut down to fit appropriately.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT PRIORITY, 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 ; 76145120
• MDR Report Key: 14018263
• Report Number: 0008010177-2022-00012
• Device Sequence Number: 5219379
• Product Code: GWO
• UDI-Device Identifier: 07613327129274
• UDI-Public: 07613327129274
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K152076
• 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): 07/12/2022

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 Model Number: 78-50040
• Device Catalogue Number: 78-50040
• Device Lot Number: 2203041030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• 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