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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, 57MM
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GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, 4-LEVEL, 57MM Back to Search Results
Model Number 1194.4057
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was not available for return as it remains in the patient.Imaging provided shows an inferior screw in a 4-level construct has backed out anteriorly past the screw blocking mechanism.The patient is reported to be asymptomatic and there are no plans for a revision surgery.The exact cause of the reported issue could not be determined.
 
Event or Problem Description
It was reported that a screw backed out of the resonate plate post-operatively.There are no plans for a revision surgery.
 
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Brand Name
RESONATE
Common Device Name
RESONATE ANTERIOR CERVICAL PLATE, 4-LEVEL, 57MM
Manufacturer (Section D)
GLOBUS MEDICAL, INC.
2560 general armistead avenue
audubon 19403
MDR Report Key11282745
Report Number3004142400-2021-00022
Device Sequence Number13632076
Product Code KWQ
UDI-Device Identifier00193982155667
UDI-Public00193982155667
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
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) 01/28/2021
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 Number1194.4057
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/08/2021
Initial Report FDA Received Date02/04/2021
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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