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

Model Number 48230000

Device Problem Fracture (1260)

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

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

This device was initially reported under mrn 0009617544-2020-00191.On 11 november 2020 additional information was received indicating that this device pertains to a second, unrelated event.

Event Description

It was reported that two xia titanium blockers fractured during implantation.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay using a back-up device.This report represents the first of the two blockers.

Event Description

It was reported, that two xia titanium blockers fractured, during implantation.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay using a back-up device.This report represents the first of the two blockers.

Manufacturer Narrative

The device was not returned for evaluation.The lot number was not provided, so a review of device history records and complaint history could not be performed.It was reported, that the main body of the blockers fractured, when they contacted the rod, during blocker insertion.The xia ii universal tightener was used for insertion.And the xia ii torque wrench was used for final tightening with the anti-torque tube.The blocker did not appear to be cross threaded, the torque applied is unknown.There was no difficult angle, and surgeon did not appear to apply excessive force.As the device was not returned, a definite cause cannot be determined.Possible causes include over-torqueing, deformed torque wrench tip, cantilever force applied, during final tightening, rod not fully reduced, and/or the torque wrench tip not fully engaged into the blocker during final tightening.H3 other text: device not returned.

• 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: 10886776
• MDR Text Key: 219181631
• Report Number: 0009617544-2020-00198
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 01/30/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1