MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM ROD DIAM 6MM CP TI L 480MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 48232480

Device Problem Fracture (1260)

Patient Problems Muscle Weakness (1967); Numbness (2415)

Event Date 12/08/2023

Event Type  Injury  

Event Description

It was reported that a patient will be revised to address one fractured es2 straight rod and two fractured xia titanium rods.The patient has reported numbness and weakness in their lower extremities.This report captures the first of two xia titanium rods.

Manufacturer Narrative

H3 other text : no product returned.

• Brand Name: XIA 3 TITANIUM ROD DIAM 6MM CP TI L 480MM
• 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: 18540156
• MDR Text Key: 333194500
• Report Number: 0009617544-2024-00013
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540560575
• UDI-Public: 04546540560575
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K142381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48232480
• Device Lot Number: 8X8
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2023
• 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: 29 YR
• Patient Sex: Male
• Patient Weight: 65 KG