MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 5.0 X 40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482315040

Device Problems Malposition of Device (2616); Unintended Movement (3026)

Patient Problems Paralysis (1997); Injury (2348)

Event Date 05/15/2018

Event Type  Injury  

Event Description

It was reported that during surgery, a screw was implanted to the thoracic vertebra and it was confirmed by x-ray that the position of the screw was bad.It was decided to check by ct imaging, which confirmed the screw was implanted in the spinal canal.Patient was brought back into surgery to reposition the screw.After surgery, the right lower limb was not moving, however, upon further follow-up it was reported the patient did not have an issue with the limb.

Manufacturer Narrative

Method: risk assessment.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.It was reported that the screw was implanted into the thoracic vertebra and the position was found to be poor via an x ray during the surgery.The positioning was confirmed by ct that the screw was implanted in the spinal canal, so it was decided to replace the screw by immediately returning to the operating room with an additional procedure.After additional procedure, the right lower limb was not moving.The patient regained control of the limb and currently has no issues.The screw remains implanted as it was repositioned.Conclusion: it is unknown how the pathway was prepared and if the surgical technique was followed.Potential root causes include: user not tapping the pathway, incorrect screw size selected, hard bone quality, incorrect trajectory, and inadequate attachment of screw to driver.Based on the information reported, incorrect trajectory is the most likely root cause, however, without x rays to confirm, a definite root cause cannot be determined.

Event Description

It was reported that during surgery, a screw was implanted to the thoracic vertebra and it was confirmed by x-ray that the position of the screw was bad.It was decided to check by ct imaging, which confirmed the screw was implanted in the spinal canal.Patient was brought back into surgery to reposition the screw.After surgery, the right lower limb was not moving, however, upon further follow-up it was reported the patient did not have an issue with the limb.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 5.0 X 40 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7598175
• MDR Text Key: 110970061
• Report Number: 3005525032-2018-00040
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540561985
• UDI-Public: (01)04546540561985
• 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: 09/22/2018

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?: No
• Device Operator: No Information
• Device Model Number: 482315040
• Device Catalogue Number: 482315040
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 08/29/2018
• Supplement Dates FDA Received: 09/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention