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

Catalog Number	78-10010
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	06/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 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 by a company representative that a revision surgery occurred related to a post-surgical site infection after initial implantation with an implant.There was no actual device malfunction reported or evidence of such, and the procedure was reported as completed successfully.
Additional Manufacturer Narrative
The reported event could not be confirmed because the information provided was not sufficient.The device history record for the ¿peek customized cranial implant kit, l¿, catalog # 78-10010, lot code # 1904031015 indicates one unit was manufactured to specification and accepted into final stock on (b)(6) 2019 with no reported discrepancies.To gain more information about the complained event the ¿infection complaints ¿ checklist customer¿ (cmfqf 13-003) was forwarded to the sales rep and reminders were sent several times.However, this checklist was not completed.Additionally, the ¿infection complaints - checklist investigator¿ (cmfqf 13-002) was completed by the manufacturing site for the affected device.For infection complaints expanded investigations are performed to assure that neither the complained device nor all related manufacturing (e.G.Environmental monitoring, sterilization validations tests) process steps could have caused the event.The complained 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.Summarizing the received information about the event, the main root cause for the reported event is most likely user related.Based on the investigation including a statistical evaluation and the dhr review of the related manufacturing and quality documents there is no indication for a not correctly working product or any systematic design, material, or manufacturing related issue.Therefore, no corrective and/or preventive actions are deemed necessary at that time.The complaint is added to the complaint trend.
Event or Problem Description
It was reported by a company representative that a revision surgery occurred related to a post-surgical site infection after initial implantation with an implant.There was no actual device malfunction reported or evidence of such, and the procedure was reported as completed successfully.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT KIT, S
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8712858
• Report Number: 0008010177-2019-00038
• Device Sequence Number: 2274976
• Product Code: GWO
• UDI-Device Identifier: 04546540730763
• UDI-Public: 04546540730763
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/08/2019

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: 78-10010
• Device Lot Number: 1904031015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1