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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 80MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 80MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 482318580
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2020
Event Type  malfunction  
Event Description
It was reported that two xia 3 titanium polyaxial screws tulip threading disengaged intra-operatively.The procedure was completed successfully with a 45 minute surgical delay.No adverse consequences or medical intervention were reported.This is the first of the two screws.
 
Event Description
It was reported that two xia 3 titanium polyaxial screws tulip threading disengaged intra-operatively.The procedure was completed successfully with a 45 minute surgical delay.No adverse consequences or medical intervention were reported.This is the first of the two screws.
 
Manufacturer Narrative
Visual inspection: the screw was returned in 2 pieces with the tulip disengaged from the shank.The blocker and rod connector were still attached to the tulip.The blocker was buried into the tulip, indicative of overtightening.There was deformation on the locking ring and a steep, deep rod indentation on the shank bulb, further indicating overtightening of the rod and the screw being angulated.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.From the xia stg: 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.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.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.It was reported that the xia 3 torque wrench was used for final tightening without the anti torque key.The rod was reported to be fully reduced, angle was not difficult, and the bottom of the tulip was not contacting the bone.It did not appear that the surgeon applied excessive force.The blocker was found buried into the screw head, along with a deep steep rod indentation on the screw, both of which are indicative of overtightening which can lead to tulip disengagement.Additionally, the anti torque key was not used which is required to be used in the surgical technique.
 
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Brand Name
XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 80MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key11030160
MDR Text Key222709576
Report Number3005525032-2020-00045
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04546540598653
UDI-Public04546540598653
Combination Product (y/n)N
PMA/PMN Number
K170496
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number482318580
Device Catalogue Number482318580
Device Lot NumberB87483
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2020
Initial Date Manufacturer Received 12/04/2020
Initial Date FDA Received12/17/2020
Supplement Dates Manufacturer Received03/31/2021
Supplement Dates FDA Received04/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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