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

Model Number 48230000

Device Problem Migration (4003)

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

Event Date 02/17/2022

Event Type  Injury  

Event Description

It was reported that 4 years post-operatively two xia 3 blockers at left and right l2 migrated out of position.Revision surgery was performed.This report captures the second blocker at right l2.

Manufacturer Narrative

Device has been received and section d has been updated.

Event Description

It was reported that 4 years post-operatively two xia 3 blockers at left and right l2 migrated out of position.Revision surgery was performed.This report captures the second blocker at right l2.

Event Description

It was reported that 4 years post-operatively two xia 3 blockers at left and right l2 migrated out of position.Revision surgery was performed.This report captures the second blocker at right l2.

Manufacturer Narrative

A visual inspection was performed.Chatter witness marks are observed on the underside of the blocker.No rod deformation witness mark is observed.Lack of rod deformation witness mark indicates that the blocker was not fully engaged or tightened onto the rod.Chatter marks also indicates that the blocker was not properly tightened onto the associated rod.Lack of rod deformation mark on the bottom of the blocker may indicate that the rod was not properly oriented in the screw tulip during final tightening.Device history records were reviewed for the corresponding lot and no relevant issues were identified.Complaint history record review was performed for this lot and subject catalog number, and no adverse trends were observed.The customer reported an event of a xia 3 titanium blocker main body migration post-op which was confirmed via correspondence with field and visual inspection.Initial report states that the primary surgery was performed on 17-oct-2017.L2-l4 were fixed with xia 3.The left and right side of the l2 set screw popped out, so a revision surgery was performed.It was reported via follow up communications that the xia 3 torque wrench and anti-torque key were both used for final tightening.It was reported that the rod was fully reduced before tightening and that the angle was not difficult and surgeon did not apply excessive force.It is unknown if the torque wrench is regularly lubricated.The most likely cause of the reported event was determined to be under tightening of the blocker during final tightening during the initial procedure.Improper placement of the rod in the screw tulip head may also have contributed to event but could not be confirmed without x-rays.

• 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: 13776710
• MDR Text Key: 288474810
• Report Number: 0009617544-2022-00034
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540560193
• UDI-Public: 04546540560193
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• 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: 9JG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2017
• 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