MAUDE Adverse Event Report: STRYKER SPINE-US 6.5X45 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482616545
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ideal sized xia serrato polyaxial screw was not available intra-operatively, and that smaller sized xia serrato polyaxial screws were implanted instead.The procedure was completed successfully with no surgical delay and no adverse consequences to the patient.This report captures the first of two xia screws.
Additional Manufacturer Narrative
Corrected data: g1 h6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
It was reported that the ideal sized xia serrato polyaxial screw was not available intra-operatively, and that smaller sized xia serrato polyaxial screws were implanted instead.The procedure was completed successfully with no surgical delay and no adverse consequences to the patient.This report captures the first of two xia screws.

• Brand Name: 6.5X45 POLYAXIAL SCREW
• 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: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 20790009
• Report Number: 0009617544-2024-00185
• Device Sequence Number: 6755122
• Product Code: NKB
• UDI-Device Identifier: 07613327352658
• UDI-Public: 07613327352658
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/14/2025

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 Catalogue Number: 482616545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown