MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 70MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482318570
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that a patient underwent revision surgery to address a xia polyaxial screw fracture and a radius rod migration.This report is for the xia polyaxial screw.
Event or Problem Description
A company representative reported that a patient underwent revision surgery approximately 1.5 years post-operatively to address a left-sided xia polyaxial screw fracture and a right-sided xia polyaxial screw migration.The patient reported experiencing mechanical low-back pain.This report is for the xia polyaxial screw that fractured.
Additional Manufacturer Narrative
Corrected data; b5, b7.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
A company representative reported that a patient underwent revision surgery approximately 1.5 years post-operatively to address a left-sided xia polyaxial screw fracture and a right-sided xia polyaxial screw migration.The patient reported experiencing mechanical low-back pain.This report is for the xia polyaxial screw that fractured.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 70MM
• 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: 16750887
• Report Number: 0009617544-2023-00015
• Device Sequence Number: 17001512
• Product Code: NKB
• UDI-Device Identifier: 04546540598646
• UDI-Public: 04546540598646
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2023

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 Model Number: 482318570
• Device Catalogue Number: 482318570
• Device Lot Number: B33284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 04/13/2023; 06/16/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 05/12/2023; 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2013
• 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 Age: 64 YR
• Patient Sex: Female