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

Catalog Number	78-50040
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abscess (1690); Unspecified Infection (1930)
Date of Event	06/05/2019
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 a peek cci was implanted, and then following the procedure there was dehiscence.The patient acquired an infection.During the revision surgery there was puss around the implant sight, so it was removed.
Additional Manufacturer Narrative
The reported event could not be confirmed, because the information provided was not sufficient.To gain more information about the complained event the sales rep was contacted.It was stated that the customer considers the complaint not as a product issue but more related to the procedure and/or related to the patient condition.Therefore no ¿infection complaints ¿ checklist customer¿ (cmfqf 13-003) was forwarded to the surgeon.
Event or Problem Description
It was reported a peek cci was implanted, and then following the procedure there was dehiscence.The patient acquired an infection.During the revision surgery there was puss around the implant sight, so it was removed.

• 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: 8699987
• Report Number: 0008010177-2019-00037
• Device Sequence Number: 1935748
• Product Code: GWO
• UDI-Device Identifier: 07613327129274
• UDI-Public: 07613327129274
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 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: 78-50040
• Device Lot Number: 1901081016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/14/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention