MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE EXTREME ANGLE ANTERIOR CERVICAL PLATE SYSTEM; RESONATE ANTERIOR CERVICAL PLATE

Model Number	1194.3042
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a screw is backing out of a resonate plate four weeks post operatively.
Additional Manufacturer Narrative
The device was not available for evaluation as it remains in the patient.Imaging provided showed a screw backing out past the blocking mechanism at the inferior level of a 2 level plate located at c5-c7 originally implanted mid- (b)(6) 2021.The resonate plate was added below a previous unknown 2 level plate (located at c3-c5) that turned into a 1 level plate (c3-c4) by being cut off at the bottom level.There is no plan for revision at this time.No determinations can be made as to the cause of the reported issue.

• Brand Name: RESONATE EXTREME ANGLE ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: RESONATE ANTERIOR CERVICAL 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 ; 6109301822
• MDR Report Key: 12855939
• Report Number: 3004142400-2021-00228
• Device Sequence Number: 17550305
• Product Code: KWQ
• UDI-Device Identifier: 00193982155353
• UDI-Public: 00193982155353
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D360198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/18/2021

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 Number: 1194.3042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Unknown