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

Catalog Number 48230000

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problem Injury (2348)

Event Date 10/21/2019

Event Type  malfunction  

Event Description

It was reported that a xia 3 blocker migrated postoperatively.The blocker was replaced during revision surgery.During the revision, another xia 3 blocker was noted to be loose, this blocker was replaced as well.This record represents the loose blocker.

Event Description

It was reported that a xia 3 blocker migrated postoperatively.The blocker was replaced during revision surgery.During the revision, another xia 3 blocker was noted to be loose, this blocker was replaced as well.This record represents the loose blocker.

Manufacturer Narrative

Visual inspection: there were no rod indentations on the bottom of the blocker indicating that the blocker was undertightened.There was some chattering on the underside of the blocker, from the rod moving against the blocker as it was rotated, most likely caused from the blocker unthreading itself from the tulip.This is likely the blocker that migrated out of the screw shown in the x ray.Functional inspection: the blocker was able to be threaded into a test screw.Device and complaint history records were reviewed, no relevant manufacturing issues or similar complaints were identified.From the xia 3 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.Line up the two arrows to achieve the final tightening torque of 12nm.Note: do not exceed 12nm during final tightening.Examination of the blocker found that there were no rod indentations on the bottom of the blocker, which would be expected for a blocker tightened to 12nm.This indicates that the blocker was under-tightened and most likely the reason why it migrated or loosened out of the tulip.

• 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: 9298096
• MDR Text Key: 174713937
• Report Number: 0009617544-2019-00121
• 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: 01/03/2020

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 Catalogue Number: 48230000
• Device Lot Number: 5A2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 12/27/2019
• Supplement Dates FDA Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Weight: 67