MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 VITALIUM ROD 4.5 X 600 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM.

Model Number 48132601

Device Problems Break (1069); Fracture (1260)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2018

Event Type  Injury  

Event Description

It was reported that the rod broke.

Manufacturer Narrative

The reported event resulted in patient revision surgery.Method: risk assessment; x-rays.Results: visual, dimensional and functional analysis could not be performed as the device was not returned.No lot # was provided, so a manufacturing record review could not be performed.Conclusion: the rods were found fractured about 9 months after the original surgery.Fusion did not occur.The x ray shows several levels of fixation at the top of the construct, and several levels of fixation at the bottom, and a section of non fixation in the middle.This, along with the curvature of the spine, could cause a bending moment.Over time this could cause the rods to fracture due to the stress and strain of the construct.However since the device was not returned for evaluation the definite root cause cannot be determined.

Event Description

It was reported that the rod broke.

• Brand Name: XIA TITANIUM 4.5 VITALIUM ROD 4.5 X 600 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7323863
• MDR Text Key: 102079699
• Report Number: 0009617544-2018-00064
• Device Sequence Number: 1
• Product Code: OSH
• UDI-Device Identifier: 04546540539663
• UDI-Public: (01)04546540539663
• Combination Product (y/n): N
• PMA/PMN Number: K121342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 48132601
• Device Catalogue Number: 48132601
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/08/2018
• Supplement Dates Manufacturer Received: 04/27/2018
• Supplement Dates FDA Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention