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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE XIA 3 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE XIA 3 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 482317580
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Failure of Implant (1924)
Event Date 08/12/2021
Event Type  malfunction  
Event Description
Patient had lumbar sacral fusion. X-rays taken the next day and discovered that sacral screws failed and underwent 2 level fusion with screws.
 
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Brand NameXIA 3
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE
2 pearl court
allendale NJ 07401
MDR Report Key13847912
MDR Text Key287618892
Report Number13847912
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/07/2022,09/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number482317580
Device Lot NumberB16147
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/07/2022
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer03/22/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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