MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UNIII AXS SCREWS, SELF-DRILLING, 1.5X5MM, 5/P; IMPLANT

Catalog Number	56-15935
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If further information becomes available, it will be submitted in a supplemental report.Facility did not save device for return.
Event or Problem Description
It was reported by the company representative that screws that were used to fixate a plate during a cranioplasty had come loose.A revision surgery was preformed to correct the issue.

• Brand Name: UNIII AXS SCREWS, SELF-DRILLING, 1.5X5MM, 5/P
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7877207
• Report Number: 0008010177-2018-00087
• Device Sequence Number: 2061092
• Product Code: HBW
• UDI-Device Identifier: 37613327090742
• UDI-Public: 37613327090742
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K151387
• 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
• Report Date (Section B): 09/14/2018

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: 56-15935
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/14/2018
• 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