MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 5.0 X 30 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 482315030

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2024

Event Type  Injury  

Event Description

It was reported that approximately 8 years post-operatively, imaging revealed a xia polyaxial screw tip fracture and the fracture of two radius vitallium rods.This report captures the xia polyaxial screw tip fracture.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 5.0 X 30 MM
• Type of Device: 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: 19056053
• MDR Text Key: 339550267
• Report Number: 0009617544-2024-00036
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540561961
• UDI-Public: 04546540561961
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 482315030
• Device Lot Number: B57882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 49 KG