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

Model Number 48230000

Device Problems No Apparent Adverse Event (3189); Migration (4003)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was reported that 14 xia 3 titanium blockers migrated post-operatively creating what's known as an 'audible spine' where noise can be heard during movement.No revision surgery is scheduled at this time.This report represents the 3rd of the 14 blockers.

Manufacturer Narrative

Describe event or problem was updated to reflect the new information that was received.

Event Description

It was initially reported that 14 xia 3 titanium blockers migrated post-operatively creating what's known as an 'audible spine' where noise can be heard during movement.Additional information indicates only 2 of the 14 devices migrated.The device captured in this report functioned as intended and did not cause or contribute to the reported event.The two migrated devices are captured in reports 3005525032-2020-00002 and 3005525032-2020-00003.This report represents the 3 of the 14 blockers.

• 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
• MDR Report Key: 9618586
• MDR Text Key: 195905952
• Report Number: 3005525032-2020-00004
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540560193
• UDI-Public: 04546540560193
• Combination Product (y/n): N
• PMA/PMN Number: K142381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48230000
• Device Catalogue Number: 48230000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1