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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 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US XIA DEFORMITY UNIPLANAR SCREW REDUCTION DIA 5.5 X 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 482365540
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 first of three screws.
 
Manufacturer Narrative
Corrected data: d4.
 
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 first of three screws.
 
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Brand Name
XIA DEFORMITY UNIPLANAR SCREW REDUCTION DIA 5.5 X 40MM
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 Key18518762
MDR Text Key333368878
Report Number0009617544-2024-00010
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07613327001358
UDI-Public07613327001358
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 Number482365540
Device Lot Number224793
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 Manufactured08/23/2022
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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