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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, EXTRA LORDOTIC, 2-LEVEL, 36MM
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GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, EXTRA LORDOTIC, 2-LEVEL, 36MM Back to Search Results
Model Number 1194.2136
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 08/17/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The malfunction of the plate/screw system was induced by user error.Excessive torque applied to the screw by the surgeon deformed the screw hole causing the screw head to advance through the plate.
 
Event or Problem Description
It was reported that the surgeon advanced a screw through the resonant plate, causing the plate and screws to be removed and replaced.
 
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Brand Name
RESONATE
Common Device Name
RESONATE ANTERIOR CERVICAL PLATE, EXTRA LORDOTIC, 2-LEVEL, 36MM
Manufacturer (Section D)
GLOBUS MEDICAL, INC.
2560 general armistead avenue
audubon 19403
MDR Report Key10575503
Report Number3004142400-2020-00112
Device Sequence Number2655999
Product Code KWQ
UDI-Device Identifier00193982155186
UDI-Public00193982155186
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K192314
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number1194.2136
Device Lot NumberETX042PA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/27/2020
Initial Report FDA Received Date09/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age45 YR
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