MAUDE Adverse Event Report: STRYKER SPINE-US XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6.5 X 50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	03829650
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We were provided two possible catalogue numbers and are pursuing more information.The catalogue number could be 03829650 or 03829645.H3: device remains implanted.
Event or Problem Description
A company representative reported that a xia polyaxial reduction screw fractured approximately 1 year and 1 month post-operatively.Revision surgery has not taken place nor been scheduled.No adverse consequences were reported.
Event or Problem Description
A company representative reported that a xia polyaxial reduction screw fractured approximately 1 year and 1 month post-operatively.Revision surgery has not taken place nor been scheduled.No adverse consequences were reported.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.H3 other text : device remains implanted.

• Brand Name: XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6.5 X 50MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 16684179
• Report Number: 0009617544-2023-00011
• Device Sequence Number: 15482753
• Product Code: NKB
• UDI-Device Identifier: 07613154407903
• UDI-Public: 07613154407903
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03829650
• Device Catalogue Number: 03829650
• Device Lot Number: 210255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• 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
• Patient Age: 74 YR
• Patient Sex: Male