MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482318550
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a revision surgery to replace a xia 3 titanium polyaxial screw with a disengaged tulip head.
Event or Problem Description
It was reported that patient underwent a revision surgery to replace a xia 3 titanium polyaxial screw with a disengaged tulip head.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records and trackwise databases were reviewed for the provided lot and no relevant manufacturing issues or similar complaints were identified.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 performed.Use the anti-torque key and the torque wrench.The anti-torque key and torque wrench come in two sizes; standard and short.Place the anti-torque key around the screw head.Place the torque wrench through the anti-torque key until it is guided into the blocker.The torque wrench indicates the optimal torque force that must be applied to the implant for final tightening.Line up the two arrows to achieve the final tightening torque of 12nm.Note: do not exceed 12nm during final tightening.Note: the short torque wrench will not fit through the standard antitorque key.Note: the es2 torque wrench or the mantis redux torque wrench may also be used as an alternative to the xia 3 torque wrench to final tighten the xia 3 blockers.The anti-torque key must be used for final tightening.The anti-torque key performs two key functions: allows the torque wrench to align with the tightening axis; helps to maximize the torque needed to lock the implant assembly.Note: the es2 counter torque tube may also be used in conjunction with the xia 3 torque wrench.As the device was not returned, a definite root cause cannot be determined.Based on the description, it appears the blocker may have been misaligned or crossthreaded during final tightening.This could cause difficulties final tightening the blocker, requiring excess torque applied to the blocker, causing the tulip to disengage.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 50MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8942147
• Report Number: 3005525032-2019-00074
• Device Sequence Number: 11482249
• Product Code: NKB
• UDI-Device Identifier: 04546540598608
• UDI-Public: 04546540598608
• Combination Product (Y/N): N
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 482318550
• Device Lot Number: B75672
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 11/07/2019
• 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
• Patient Age: 83 YR
• Patient Weight: 50