MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 48230000

Device Problems Fracture (1260); Material Deformation (2976); Migration (4003)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 11/09/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent revision surgery to address two fractured xia rods and a migrated xia blocker at right s1.The surgeon reported that metallosis was observed at the l5/s1 site and there was no evidence of osteolysis around any of the lower screws.This report captures the migrated xia blocker.

Event Description

It was reported that a patient underwent revision surgery to address two fractured xia rods and a migrated xia blocker at right s1.The surgeon reported that metallosis was observed at the l5/s1 site and there was no evidence of osteolysis around any of the lower screws.This report captures the migrated xia blocker.

Manufacturer Narrative

H6 codes have been updated to reflect receipt of the device and conclusion of the investigation.

• Brand Name: XIA 3 TITANIUM BLOCKER
• 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: 15936139
• MDR Text Key: 305040732
• Report Number: 0009617544-2022-00114
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540560193
• UDI-Public: 04546540560193
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48230000
• Device Catalogue Number: 48230000
• Device Lot Number: 8EG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2018
• 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: 70 YR
• Patient Sex: Female