MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UNIII AXS SCREWS, SELF-DRILLING, 1.5X4MM, 5/P; IMPLANT

Catalog Number	56-15934
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/03/2020
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.Device not available to stryker for evaluation, and no explanation was provided.
Event or Problem Description
It was reported by a company representative that a patient developed a post-surgical infection after a procedure with an implant.There are no additional details available at this time.
Additional Manufacturer Narrative
Per update received on 6/17/2020, the surgeon does not think that the stryker device caused/contributed to the event.A report is not needed.As this initial mdr, was pushed through, this supplemental is to clarify that an mdr was not needed as there was no malfunction nor did the device cause or contribute to an adverse event.
Event or Problem Description
It was reported by a company representative that a patient developed a post-surgical infection after a procedure with an implant.There are no additional details available at this time.

• Brand Name: UNIII AXS SCREWS, SELF-DRILLING, 1.5X4MM, 5/P
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• MDR Report Key: 10173607
• Report Number: 0008010177-2020-00032
• Device Sequence Number: 3600056
• Product Code: HBW
• UDI-Device Identifier: 37613327090735
• UDI-Public: 37613327090735
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 06/19/2020

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: 56-15934
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1