MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 48130000

Device Problem Migration (4003)

Patient Problem Injury (2348)

Event Date 03/09/2020

Event Type  Injury  

Manufacturer Narrative

Hospital retained.

Event Description

It was reported that four xia titanium 4.5 blockers disengaged from their respective screws three years post-operatively and were discovered via x-ray.Revision surgery has occurred.This record represents blocker 2 of 4.

Event Description

It was reported that four xia titanium 4.5 blockers disengaged from their respective screws three years post-operatively and were discovered via x-ray.Revision surgery has occurred.This record represents blocker 2 of 4.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.However, post-op x-rays were provided showing 2 rods and 4 blockers migrated out of the screw.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.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 done by utilizing the anti-torque key and the torque wrench.The torque wrench indicates the appropriate torque that has to be applied to the implant for final tightening.Line up the arrow to the line in order to achieve this final tightening torque of 8 nm.Note: during final tightening, 8 nm must not be exceeded.Inappropriate or improper surgical placement of this device may cause distraction or stress shielding of the graft or fusion mass.This may contribute to failure of an adequate fusion mass to form.While the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.It was reported that screws did not give enough polyaxiality and the surgeon needed to compress.Surgeon over tightened and feels this was an issue with over compressing.The root cause of the reported event is multi-factorial and include: over-tightening of the blockers, surgeon applied too much force to the spine during compression, pseudarthrosis.

• Brand Name: XIA TITANIUM 4.5 BLOCKER
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9936111
• MDR Text Key: 192184559
• Report Number: 0009617544-2020-00060
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540448897
• UDI-Public: 04546540448897
• Combination Product (y/n): N
• PMA/PMN Number: K152632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48130000
• Device Catalogue Number: 48130000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention