MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE EXTREME ANGLE ANTERIOR CERVICAL PLATE SYSTEM; RESONATE ANTERIOR CERVICAL PLATE, 3-LEVEL, 48MM

Model Number	1194.3048
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery was done to remove and replace (8) screws, due to 2 screws backing out of a resonate plate 7 months post-operatively.
Additional Manufacturer Narrative
The device could not be provided for evaluation as it remains in the patient.No determinations could 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, 3-LEVEL, 48MM
• 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: 15733986
• Report Number: 3004142400-2022-00154
• Device Sequence Number: 2907662
• Product Code: KWQ
• UDI-Device Identifier: 00193982155377
• UDI-Public: 00193982155377
• 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
• Device Explanted 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
• Report Date (Section B): 10/28/2022

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: 1194.3048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Race: White