MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE EXTREME ANGLE ANTERIOR CERVICAL PLATE SYSTEM; RESONATE ANTERIOR CERVICAL PLATE, 3-LEVEL, 45MM

Model Number	1194.3045
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that screws are backing out of the resonate plate post-operatively.
Additional Manufacturer Narrative
The device was not available for evaluation as it remains in the patient.The imaging provided shows the screw head sticking out of the plate.It is possible that the screws were not fully seated in the screw hole during insertion; however, an exact cause of the reported issue could not be determined.
Additional Manufacturer Narrative
The two screws that backed out of the plate were returned for evaluation.The imaging provided shows the screw head sticking out of the plate.It is possible that the screws were not fully seated in the screw hole during insertion; however, an exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that screws are backing out of the resonate plate post-operatively.

• Brand Name: RESONATE EXTREME ANGLE ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: RESONATE ANTERIOR CERVICAL PLATE, 3-LEVEL, 45MM
• 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 Key: 14873581
• Report Number: 3004142400-2022-00102
• Device Sequence Number: 5102763
• Product Code: KWQ
• UDI-Device Identifier: 00193982155360
• UDI-Public: 00193982155360
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2022

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 Number: 1194.3045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male