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U.S. Department of Health and Human Services

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

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STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 482318550
Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)
Patient Problem Injury (2348)
Event Date 07/30/2019
Event Type  Injury  
Event Description
It was reported that patient underwent a revision surgery to replace a xia 3 titanium polyaxial screw with a disengaged tulip head.
 
Event Description
It was reported that patient underwent a revision surgery to replace a xia 3 titanium polyaxial screw with a disengaged tulip head.
 
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.
 
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Brand Name
XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 50MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key8942147
MDR Text Key155970057
Report Number3005525032-2019-00074
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04546540598608
UDI-Public04546540598608
Combination Product (y/n)N
PMA/PMN Number
K142381
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 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
Device Operator Health Professional
Device Catalogue Number482318550
Device Lot NumberB75672
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/30/2019
Initial Date FDA Received08/28/2019
Supplement Dates Manufacturer Received10/10/2019
Supplement Dates FDA Received11/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age83 YR
Patient Weight50
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