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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, 4-LEVEL, 60MM
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GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, 4-LEVEL, 60MM Back to Search Results
Model Number 1194.4060
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/27/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation and initial observation shows cuts and gouges to the damaged screw hole, which may have been caused by the thread of the screw.It is possible that the screw was inserted at an unusual angle and the thread cut into the screw hole in the plate.However, the exact cause of the reported issue could not be determined.
 
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, 4-LEVEL, 60MM
Manufacturer (Section D)
GLOBUS MEDICAL, INC.
2560 general armistead avenue
audubon 19403
MDR Report Key10900514
Report Number3004142400-2020-00148
Device Sequence Number16902617
Product Code KWQ
UDI-Device Identifier00193982155674
UDI-Public00193982155674
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) 11/20/2020
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 Number1194.4060
Device Lot NumberETX015GA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/27/2020
Initial Report FDA Received Date11/25/2020
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;
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