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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US XIA DEFORMITY UNIPLANAR SCREW REDUCTION DIA 5.5 X 35MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US XIA DEFORMITY UNIPLANAR SCREW REDUCTION DIA 5.5 X 35MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 482365535
Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/18/2023
Event Type  malfunction  
Event Description
It was reported that during a revision surgery to address distal junction kyphosis, the surgeon noted tulip disengagements of three of the previously implanted xia uniplanar reduction screws.The screws were explanted and replaced.This report captures the second of three screws.
 
Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.
 
Event Description
It was reported that during a revision surgery to address distal junction kyphosis, the surgeon noted tulip disengagements of three of the previously implanted xia uniplanar reduction screws.The screws were explanted and replaced.This report captures the second of three screws.
 
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Brand Name
XIA DEFORMITY UNIPLANAR SCREW REDUCTION DIA 5.5 X 35MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR   33610
Manufacturer Contact
rita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key18519803
MDR Text Key332943664
Report Number0009617544-2024-00008
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07613327000900
UDI-Public07613327000900
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113666
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number482365535
Device Lot Number198577
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2024
Is the Reporter a Health Professional? No
Date Manufacturer Received03/27/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age12 YR
Patient SexFemale
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