MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UNIII AXS SCREWS, SELF-DRILLING, 1.5X3MM, 5/P; IMPLANT

Catalog Number	56-15933
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received at the manufacturer for testing.An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported that the patient had post operative irritation.Surgeon reviewed a post op scan which showed the plate and screw were loose, which could result in damage of bone, tissue or structures, requiring surgery to prevent permanent impairment.There was a revision surgery and devices were removed and fixated.He procedure was completed successfully.There was no clinically significant delay.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document the device evaluation.
Event or Problem Description
It was reported that the patient had post operative irritation.Surgeon reviewed a post op scan which showed the plate and screw were loose, which could result in damage of bone, tissue or structures, requiring surgery to prevent permanent impairment.There was a revision surgery and devices were removed and fixated.He procedure was completed successfully.There was no clinically significant delay.

• Brand Name: UNIII AXS SCREWS, SELF-DRILLING, 1.5X3MM, 5/P
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 16537274
• Report Number: 0008010177-2023-00014
• Device Sequence Number: 15018942
• Product Code: GWO
• UDI-Device Identifier: 37613327090759
• UDI-Public: 37613327090759
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K112557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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: 56-15933
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown