MAUDE Adverse Event Report: STRYKER SPINE-US 7.5X45 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482617545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the shank of a xia polyaxial screw fractured and could not be removed from the patient.No adverse consequences were reported.The fractured screw was observed in a planned revision surgery due to adjacent intervertebral disorders and unrelated to any issue with the device.It is unknown if the screw fractured post-operatively or intra-operatively during the revision surgery.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.Additional data: d4, d6a, d9, h3, h4, corrected data: g1.
Event or Problem Description
A company representative reported that the shank of a xia polyaxial screw fractured and could not be removed from the patient.No adverse consequences were reported.The fractured screw was observed in a planned revision surgery due to adjacent intervertebral disorders and unrelated to any issue with the device.It is unknown if the screw fractured post-operatively or intra-operatively during the revision surgery.

• Brand Name: 7.5X45 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: 20304374
• Report Number: 0009617544-2024-00122
• Device Sequence Number: 7588443
• Product Code: NKB
• UDI-Device Identifier: 07613327351408
• UDI-Public: (01)07613327351408(11)181116(10)B87554
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 01/21/2025

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: 482617545
• Device Lot Number: B87554
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2018
• 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