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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US 9.5X90 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US 9.5X90 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 482619590
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
Event Type  malfunction  
Event Description
It was reported that during a scheduled revision, the tulip of a xia serrato polyaxial screw broke off during screw removal.While replacing the serrato screw, the tulip of a xia 3 polyaxial screw also broke off.All pieces of the first screw were removed; however, the shaft of the second screw remains in the patient.Surgery was successfully completed with a 30 minute delay.No adverse consequences or medical intervention were reported.This report will represent the serrato screw.
 
Event Description
It was reported that during a scheduled revision, the tulip of a xia serrato polyaxial screw broke off during screw removal.While replacing the serrato screw, the tulip of a xia 3 polyaxial screw also broke off.All pieces of the first screw were removed; however, the shaft of the second screw remains in the patient.Surgery was successfully completed with a 30 minute delay.No adverse consequences or medical intervention were reported.This report will represent the serrato screw.
 
Manufacturer Narrative
Visual: visual inspection confirmed that the tulip head had disengaged from the shank of the screw.There is wear on the outer edge of the shank head from the tulip.There is deformation on shank head from the rod.This deformation is on the edge of the shank head, same side as outer edge wear.Base of tulip shows wear as well, where it was in contact with shank head.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The location and degree of wear on the tulip head base and screw shank head indicates the tulip head was at a high degree of angulation with respect to the shank when final tightening occurred.The deformation on shank head from the rod is deeper than expected for a final tightening of 12nm.This deep deformation is indicative of over tightening of the rod.Serrato surgical technique was reviewed, the following was found to be relevant: note: the universal tightener is not to be used for final tightening.Use the anti-torque key and the torque wrench or audible torque wrench to final tighten the 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.Place the anti-torque key over the screw head.Place the torque wrench or audible torque wrench through the anti-torque key 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.If using the audible torque wrench, the blocker is completely tightened to 12nm when the audible torque wrench clicks once.Caution: extra caution is advised in the following cases: the rod is not horizontally placed into the screw head.The rod is high in the screw head.An acute convex or concave bend is contoured into the rod.The most likely cause of the reported event is due to over tightening of rod and the high angulation of the tulip to the screw.The deep indentation in the shank bulb is indicative of over tightening of the rod.The wear on the shank head and tulip base is indicative of over angulation of the screw.
 
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Brand Name
9.5X90 POLYAXIAL SCREW
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key11194637
MDR Text Key227579399
Report Number3005525032-2021-00003
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07613327351576
UDI-Public07613327351576
Combination Product (y/n)N
PMA/PMN Number
K170496
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 05/26/2021
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 Number482619590
Device Catalogue Number482619590
Device Lot NumberB67331
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2021
Initial Date Manufacturer Received 12/21/2020
Initial Date FDA Received01/19/2021
Supplement Dates Manufacturer Received04/29/2021
Supplement Dates FDA Received05/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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