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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgical procedure the implant was smaller than expected and the contour was not as expected.There was no significant surgery delay, no reported adverse consequences and the surgery was completed successfully.
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 : implanted.
Event or Problem Description
It was reported that during the surgical procedure the implant was smaller than expected and the contour was not as expected.There was no significant surgery delay, no reported adverse consequences and the surgery was completed successfully.
Additional Manufacturer Narrative
Update: h4, h6.The reported event could not be confirmed as no intra-operative images were provided.A sketch was provided, which indicated that the peek implant required modification in the posterior area of the implant.There was a gap present posteriorly upon insertion of the implant.In an attempt to reduce the posterior gap, the implant was burred to be thinner and not as proud.This did not fully result in the implant sitting flush, and the implant was installed with a slight offset.The peek cci design team performed an analysis of the peek implant design.The design steps of the implant were reviewed and determined to be performed in accordance to the applicable procedures.The symmetry and shape of the implant was reviewed.The implant meets the native bony contour well with good symmetry to the mirrored skull side.The posterior area of the implant was further looked at, but no asymmetry or gap is present in the design.The ct scan used for the implant design was approx.1 year old at the time of implant design.The applicable warning was displayed in the design proposal, but anatomical changes could occur in this period of time affecting the fit and requiring modification.Overall, no deviation in the implant design was found.The implant was designed as requested by the customer and according to all quality instructions.H3 other text : used in surgery.

• 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 ; 7614888208
• MDR Report Key: 17183205
• Report Number: 0008010177-2023-00045
• Device Sequence Number: 6518480
• Product Code: GWO
• UDI-Device Identifier: 07613327129274
• UDI-Public: 07613327129274
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 08/07/2023

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: 2304261062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• 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