MAUDE Adverse Event Report: STRYKER SPINE-US XIA LP POLYAXIAL SCREW 6.5 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	03821645
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a scheduled revision surgery to remove implants it was noticed that the tip of a previously implanted xia polyaxial screw at l5 left had fractured.The procedure was completed successfully and the tip was left in the patient.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.
Event or Problem Description
It was reported that during a scheduled revision surgery to remove implants it was noticed that the tip of a previously implanted xia polyaxial screw at l5 left had fractured.The procedure was completed successfully and the tip was left in the patient.

• Brand Name: XIA LP POLYAXIAL SCREW 6.5 X 45MM
• 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: 19645133
• Report Number: 0009617544-2024-00107
• Device Sequence Number: 6632774
• Product Code: NKB
• UDI-Device Identifier: 04546540149244
• UDI-Public: (01)04546540149244(11)070606(10)076691
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/13/2024

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: 03821645
• Device Lot Number: 076691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2007
• 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: Male