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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6.5 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6.5 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 03829645
Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/28/2021
Event Type  malfunction  
Event Description
It was reported that during final tightening, a xia deformity reduction long arm polyaxial screw "burst open" intra-operatively.A piece fell into the patient's body and was retrieved.No adverse consequences, or medical intervention were reported. the procedure was completed successfully with another device and an unknown surgical delay.
 
Manufacturer Narrative
Visual inspection confirmed tulip head is disengaged from screw shank.There is a deep deformation on shank bulb tending towards one side.There is deformation on underside of tulip head, indicating excessive force applied to an over angulated screw.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.It was reported that the blocker was cross threaded in the tulip head during final tightening.Cross threading of blocker may add additional stress and/or deformation to tulip head which may have contributed to reported event of tulip disengagement.The most likely cause of the reported event was determined to be insertion of a cross threaded blocker into an over angulated screw.
 
Event Description
It was reported that during final tightening, a xia deformity reduction long arm polyaxial screw "burst open" intra-operatively.A piece fell into the patient's body and was retrieved.No adverse consequences, or medical intervention were reported. the procedure was completed successfully with another device and an 8 minute surgical delay.
 
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Brand Name
XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6.5 X 45MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key12046550
MDR Text Key258958233
Report Number0009617544-2021-00112
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07613154407897
UDI-Public07613154407897
Combination Product (y/n)N
PMA/PMN Number
K061854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/27/2021
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 Number03829645
Device Catalogue Number03829645
Device Lot Number208155
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2021
Initial Date Manufacturer Received 05/31/2021
Initial Date FDA Received06/22/2021
Supplement Dates Manufacturer Received09/27/2021
Supplement Dates FDA Received10/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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