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

Catalog Number	78-50040
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/13/2018
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 unable to be returned.
Event or Problem Description
It was reported that an implant was removed due to infection.Another exact implant was manufactured to replace the first one.
Event or Problem Description
It was reported that an implant was removed due to infection.Another exact implant was manufactured to replace the first one.
Additional Manufacturer Narrative
The reported event could not be confirmed, because the information provided was not sufficient.The customer stated that the infection is unrelated to the implant itself.Thus, there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.The complaint is added to the complaint trend.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT PRIORITY, XL
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7947235
• Report Number: 0008010177-2018-00098
• Device Sequence Number: 10998126
• Product Code: GWO
• UDI-Device Identifier: 07613327129274
• UDI-Public: 07613327129274
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/28/2019

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: 78-50040
• Device Lot Number: 1710171012
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 03/28/2019
• 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