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

Catalog Number	78-10030
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation as it was discarded by the facility at their location.If additional information is received it will be reported in a supplemental report.The product was discarded by the facility at their location.
Event or Problem Description
It was reported by the company representative that after implanting a peek implant, the patient acquired an infection and the device was removed.The facility discarded the flap in the operating room and revision surgery is planned.
Event or Problem Description
It was reported by the company representative that after implanting a peek implant, the patient acquired an infection and the device was removed.The facility discarded the flap in the or and revision surgery is planned.
Additional Manufacturer Narrative
Evidence provided conclude this was a non-reportable event and therefore, this does not constitute an mdr.In this event, patient had a pre-existing infection at the time of device implantation.Device performed as intended and there was no evidence to show device malfunctioned.Medical expert concluded the device did not cause or contribute to patient's infection.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT KIT, L
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8509980
• Report Number: 0008010177-2019-00015
• Device Sequence Number: 19321620
• Product Code: GWO
• UDI-Device Identifier: 04546540730787
• UDI-Public: 04546540730787
• 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): 05/22/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 78-10030
• Device Lot Number: 1808081002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1