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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US 8.5X70 MEDIAL BIASED ANGLE POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US 8.5X70 MEDIAL BIASED ANGLE POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 482678570
Device Problem Material Separation (1562)
Patient Problem Injury (2348)
Event Date 05/27/2020
Event Type  Injury  
Manufacturer Narrative
Product return clarification: the screw remains implanted; however, the disengaged tulip head has been returned.
 
Event Description
It was reported that a serrato medial biased polyaxial screw tulip disengaged intra-operatively.During revision surgery, the screw head came off when the final attempt was made to attach the offset connector to the screw.Since the screw body was firmly fixed, it could not be removed and remains in the patient.
 
Manufacturer Narrative
Visual inspection: only the tulip of the screw was returned.There was deformation on the locking ring indicating that the tulip disengaged from the shank on that side.The shank was not returned.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.Excessive torsional force applied to the screw may cause the tulip to disengage as according to the surgical technique.Additionally, it was unknown how the rod was reduced.If the rod is not fully reduced in the tulip before final tightening, this can cause additional force to be applied to final tighten the blocker as additional force is required to also reduce the rod.This excess force may cause the tulip to disengage.
 
Event Description
It was reported that a serrato medial biased polyaxial screw tulip disengaged intra-operatively.During revision surgery, the screw head came off when the final attempt was made to attach the offset connector to the screw.Since the screw body was firmly fixed, it could not be removed and remains in the patient.
 
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Brand Name
8.5X70 MEDIAL BIASED ANGLE POLYAXIAL SCREW
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key10185957
MDR Text Key196155143
Report Number3005525032-2020-00029
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07613327351316
UDI-Public07613327351316
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 08/27/2020
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 Model Number482678570
Device Catalogue Number482678570
Device Lot NumberB95660
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2020
Initial Date Manufacturer Received 05/27/2020
Initial Date FDA Received06/23/2020
Supplement Dates Manufacturer Received07/30/2020
Supplement Dates FDA Received08/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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