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

Model 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	03/25/2020
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.Device was discarded at facility.
Event or Problem Description
It was reported by the sales representative that there was an infection after implantation of a plate.The surgeon plans to remove and replace the implant.There was no mention of product failure/malfunction.
Event or Problem Description
It was reported by the sales representative that there was an infection after implantation of a plate.The surgeon plans to remove and replace the implant.There was no mention of product failure/malfunction.
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.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.It has been mentioned however in the checklist that ¿(¿) surgeon and rep do not believe that stryker product caused the infection (¿)¿.In sum, the review of the document did not provide any indication that the reported infection was related to the implant in question.Further, in an email correspondence from (b)(6) 2020, the sales rep stated that, ¿(¿) this isn¿t anything more than an infection and wash out, in which case the plate was thrown away and they are asking for a new one.The way i understand it, the plate did not cause the infection (¿)¿.A revision surgery is planned, but is delayed due to the covid situation.Attempts to establish the cause of the infection as well as the date of revision were made several times.No further info could be provided.

• 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
• MDR Report Key: 9934743
• Report Number: 0008010177-2020-00021
• Device Sequence Number: 19536660
• Product Code: GWO
• UDI-Device Identifier: 04546540730787
• UDI-Public: 04546540730787
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K121153
• 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): 12/04/2020

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: 78-10030
• Device Catalogue Number: 78-10030
• Device Lot Number: 2001101006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 12/05/2020
• 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