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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. GLOBUS THREADED ROD THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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GLOBUS MEDICAL, INC. GLOBUS THREADED ROD THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 6135.0010
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/09/2020
Event Type  malfunction  
Event Description
Globus threaded rod tip sheared off during procedure (anterior lumbar interbody fusion with pedicle screw fixation). The tip was embedded in the cage and the surgeon was unable to remove. Intentionally retained. Fda safety report id# (b)(4).
 
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Brand NameGLOBUS THREADED ROD
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
GLOBUS MEDICAL, INC.
audubon PA 19403
MDR Report Key10534922
MDR Text Key207161172
Report NumberMW5096607
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00889095311297
UDI-Public(01)00889095311297(10)JNW308CD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number6135.0010
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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