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

Catalog Number	78-10030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/22/2023
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.
Event or Problem Description
It was reported that the a revision surgery was performed to remove the implant.
Event or Problem Description
It was reported that the a revision surgery was performed to remove the implant.
Additional Manufacturer Narrative
The reported event (infection) could not be confirmed as no evidence, e.G.Lab results, were provided.The sales rep was contacted for further information regarding the event.He spoke with the surgeon, who reported the infection was a bacterial infection, but he did not know the cause or provided any other additional information.The implant was originally implanted (b)(6) 2023 and explanted on (b)(6) 2023 due to the infection.The peek implant is shipped non-sterile and sterilized at the hospital.A medical expert was consulted in a similar case that is comparable and stated ¿[u]nless there is evidence that there was ineffective sterilization, the implant itself did not cause or contribute to the infection¿.In sum, the provided information and document review did not provide any indication that the reported infection was related to the product.Based on statistical evaluation, there is no indication for an incorrectly working product or any design, material or manufacturing related issue.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT KIT, L
• 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: 17551032
• Report Number: 0008010177-2023-00054
• Device Sequence Number: 12476236
• Product Code: GWO
• UDI-Device Identifier: 04546540730787
• UDI-Public: 04546540730787
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 78-10030
• Device Lot Number: 2304251014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2023
• 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: Required Intervention
• Patient Sex: Unknown