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

Model Number	1194.3045
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imaging provided shows the inferior screw has backed out anteriorly past the screw blocking mechanism.The exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that a revision was done due to a screw which had backed out of the resonate plate post-operatively.
Additional Manufacturer Narrative
Imaging provided shows the inferior screw has backed out anteriorly past the screw blocking mechanism.Evaluation of the returned device shows 3 blocking mechanisms which are broken.The exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that a revision was done due to a screw which had backed out of the resonate plate post-operatively.

• Brand Name: RESONATE
• Common Device Name: RESONATE ANTERIOR CERVICAL PLATE, 3-LEVEL, 45MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11755632
• Report Number: 3004142400-2021-00082
• Device Sequence Number: 11027647
• Product Code: KWQ
• UDI-Device Identifier: 00193982155360
• UDI-Public: 00193982155360
• 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: 2021
• Device Explanted Year: 2021
• 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): 06/10/2021

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: 1194.3045
• Device Lot Number: ETX098UA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/11/2021
• 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
• Patient Age: 74 YR