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

Model Number	78-10010
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	05/23/2023
Type of Reportable Event	Serious Injury
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 : device will remain at the account.
Event or Problem Description
It was reported that during the procedure, the surgeon noticed the implant was not the accurate size (too small) and the implant was not used.
Additional Manufacturer Narrative
Updated: h4, h6.The reported event could not be confirmed as no intra-operative images were provided.Further, no post-op ct scan was received, so the investigation performed is limited.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 freqi procedures.The implant is designed with the requested features to fit the patient's defect.The implant was designed with a good symmetrical fit as shown in the slice images.Overall, no deviation in the implant design was found.The implant was designed as requested by the customer and according to all quality instructions.Further, the dhr rereview showed that the implant was manufactured to specification.H3 other text : not available.
Event or Problem Description
It was reported that during the procedure, the surgeon noticed the implant was not the accurate size (too small) and the implant was not used.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT KIT, S
• 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: 17080764
• Report Number: 0008010177-2023-00033
• Device Sequence Number: 6273326
• Product Code: GWO
• UDI-Device Identifier: 04546540730763
• UDI-Public: 04546540730763
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K121153
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 78-10010
• Device Catalogue Number: 78-10010
• Device Lot Number: 2211091045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown