MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM MONOAXIAL SCREW DIA 6.5 X 55 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482306555
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was revised to address a fractured xia monoaxial screw.
Additional Manufacturer Narrative
Additional data: b5, d4, d9, h3, h4.H6 codes have been updated to reflect conclusion of the investigation.
Event or Problem Description
A patient was revised approximately 8 years post-operatively to address a fractured xia monoaxial screw.

• Brand Name: XIA 3 TITANIUM MONOAXIAL SCREW DIA 6.5 X 55 MM
• 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: 19442009
• Report Number: 0009617544-2024-00096
• Device Sequence Number: 8455995
• Product Code: NKB
• UDI-Device Identifier: 04546540561527
• UDI-Public: (01)04546540561527(11)20140407(10)B41239
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: 482306555
• Device Lot Number: B41239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 06/01/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2014
• 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