MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, 2-LEVEL, 34MM

Model Number	1194.2034
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation as it remains in the patient.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 at c6 beyond the locking mechanism post-operatively.There are no plans for a revision surgery.
Additional Manufacturer Narrative
The device was not available for evaluation as it remains in the patient.The inferior two sliders were both broken at the time of the revision surgery.The inferior sliders and screws were removed and provided; however the plate and remaining screws were left implanted.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 revision was completed due to screw backing out of the resonate plate at c6 beyond the locking mechanism post-operatively.

• Brand Name: RESONATE
• Common Device Name: RESONATE ANTERIOR CERVICAL PLATE, 2-LEVEL, 34MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11261306
• Report Number: 3004142400-2021-00021
• Device Sequence Number: 3845884
• Product Code: KWQ
• UDI-Device Identifier: 00193982154851
• UDI-Public: 00193982154851
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 01/27/2021

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: 1194.2034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other