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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE PLATE
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GLOBUS MEDICAL, INC. RESONATE; RESONATE PLATE Back to Search Results
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device could not be provided for evaluation as it remains in the patient.The imaging provided shows the head of the screw at the bottom level is protruding partially from the plate and what appears to be a small metal fragment beside it, possibly a piece of the locking slider.No determinations could be made as to the cause of the reported issue.
 
Event Description
It was reported that a screw is backing out of a resonate plate post operatively.
 
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Brand Name
RESONATE
Type of Device
RESONATE PLATE
Manufacturer (Section D)
GLOBUS MEDICAL, INC.
2560 general armistead avenue
audubon PA 19403
Manufacturer (Section G)
GLOBUS MEDICAL, INC.
2560 general armistead avenue
audubon PA 19403
Manufacturer Contact
daniel paul
2560 general armistead avenue
audubon, PA 19403
6109301800
MDR Report Key18838108
MDR Text Key337778551
Report Number3004142400-2023-00135
Device Sequence Number1
Product Code KWQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received08/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Outcome(s) Other;
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