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

Model Number 48289999

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 07/13/2020

Event Type  Injury  

Event Description

It was reported that a patient presented to the hospital with "complaints".Upon review of xray, it was observed that two xia 3 titanium blockers had come loose from the screw head.Revision surgery has been performed.This report captures the first of two blockers.

Event Description

It was reported that a patient presented to the hospital with "complaints".Upon review of xray, it was observed that a xia 3 titanium blocker had come loose from the screw head.Revision surgery has been performed.

Manufacturer Narrative

Visual inspection: the blocker was returned and showed chattering on the bottom of the blocker, caused by contact with the rod as the blocker migrated out of the screw tulip.This is the most likely blocker to have migrated out.The initial indentations are lighter than what is expected for 12nm of torque, indicating this blocker may have been undertightened.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: once the correction procedures have been carried out and the spine is fixed in a satisfactory position, the final tightening of the blockers is performed.Use the anti-torque key and the torque wrench.The anti-torque key and torque wrench come in two sizes; standard and short.Place the anti-torque key around the screw head.Place the torque wrench through the anti-torque key until it is guided into the blocker.The torque wrench indicates the optimal torque force that must be applied to the implant for final tightening.The surgical technique outlines the steps for final tightening.The blockers must be final tightened to 12nm.Due to the indentations on the blocker, it is likely the blocker was not fully tightened to 12nm.Other possible root causes that could have contributed to the event include patient fall, excessive post op activity, poor fixation construct, and/or poor bone quality.

• 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: 10384492
• MDR Text Key: 202182308
• Report Number: 3005525032-2020-00035
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540671431
• UDI-Public: 04546540671431
• Combination Product (y/n): N
• PMA/PMN Number: K142381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48289999
• Device Catalogue Number: 48230000
• Device Lot Number: 65A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention