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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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ALPHATEC SPINE, INC. INVICTUS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 15100
Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)
Event Date 02/25/2021
Event Type  Malfunction  
Event Description

This trauma patient required surgical procedure l2 through l5 percutaneous posterolateral instrumented fixation using the alphatec spinal fixation system. Three months after surg. It was identified by x-ray that one of the screw head tabs had not detached correctly/entirely with a portion(approx. 1 cm) remaining in the spine with one of the screws.

 
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Brand NameINVICTUS
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
ALPHATEC SPINE, INC.
1950 camino vida roble
carlsbad CA 92008
MDR Report Key11893063
MDR Text Key252912261
Report Number11893063
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
Type of Report Initial
Report Date 05/25/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/27/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number15100
Device Catalogue Number15100
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/25/2021
Event Location No Information
Date Report TO Manufacturer05/27/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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