MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM ROD DIAM 6MM TI ALLOY L 480MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 48233480

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

Prdouct still reamined implanted in patient.

Event Description

It was reported that two rods dislodged post op.The products are still implanted.No adverse consequences to the patient has been reported.

Manufacturer Narrative

Method: x-ray review, nc/capa history review, labelling review, risk assessment result: the customer reported event was confirmed via x rays.The device is still implanted in the patient therefore, device evaluation could not be performed.Lot # has not been provided , therefore, product history review could not be performed.X rays provided show the rods slipped out of the closed head screws.Ant- torque not used during procedure.There were zero intraoperative complications.Post-op activity of the patient is unknown.Conclusion: as stated in the ifu patient post op activity, patient fall and length of implantation could have also contributed to the event.Additionally, not using anti torque when tightening down the blocker could have contributed as it could result in too much torque being applied to the set screw, possibly deforming it and reducing the surface area contacting the rod holding it in place.However, as the device is still implanted, a definite root cause cannot be confirmed without evaluating the devices.

Event Description

It was reported that two rods dislodged post op.The products are still implanted.No adverse consequences to the patient has been reported.

• Brand Name: XIA 3 TITANIUM ROD DIAM 6MM TI ALLOY L 480MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8119023
• MDR Text Key: 129193779
• Report Number: 0009617544-2018-00284
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613154918454
• UDI-Public: 07613154918454
• Combination Product (y/n): N
• PMA/PMN Number: K113666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48233480
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1