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

Model Number	78-50030
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/24/2019
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 recently implanted customized cranial implant was being removed due to infection.
Additional Manufacturer Narrative
The reported event could not be confirmed, as the provided information was insufficient.To gain more information about the complained event, the ¿infection complaints ¿ checklist customer¿ (b)(4) was forwarded to the sales rep.This checklist has been completed and has mentioned in the document that the implant was sterilized 1-2 days before surgery.However, further details such as the type of organism and patient¿s medical history (e.G.Infection prior to surgery or virus infection like hiv or hepatitis) were not provided.In sum, the review of the document did not provide any indication that the reported infection was related to the implant in question.Additionally, the ¿infection complaints - checklist investigator¿ (b)(4) was completed by the manufacturing site for the affected device.For infection complaints, expanded investigations are performed to assure that neither the reported device nor all related manufacturing (e.G.Environmental monitoring, sterilization validations tests) process steps could have caused the event.The reported device is delivered non-sterile and the sterilization parameters indicated in the corresponding instruction for use are validated.Indications for any device or manufacturing related problems were not found.Based on the investigation, the dhr review of the related manufacturing and quality documents and the results from the expanded investigation at the manufacturer site, there is no indication for an incorrectly working product or any design, material or manufacturing related issue.H3 other text : device not available for return.
Event or Problem Description
It was reported that recently implanted customized cranial implant was being removed due to infection.

• 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: 8898335
• Report Number: 0008010177-2019-00049
• Device Sequence Number: 11116003
• 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): 04/13/2021

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 Model Number: 78-50030
• Device Catalogue Number: 78-50030
• Device Lot Number: 1907071005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 04/13/2021
• 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: Required Intervention