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
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Paralysis (1997); Injury (2348)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7598175
• Report Number: 3005525032-2018-00040
• Device Sequence Number: 13497251
• Product Code: NKB
• UDI-Device Identifier: 04546540561985
• UDI-Public: (01)04546540561985
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: 482315040
• Device Catalogue Number: 482315040
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 09/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention