MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, 3-LEVEL, 51MM

Model Number	1194.3051
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision was needed to replace resonate screws backing out of the plate post-operatively.
Additional Manufacturer Narrative
The device was available for evaluation.It was reported that the screws backed out past the locking mechanisms at the bottom level of a 3 level 51mm resonate plate at c4-c7.The original surgery occurred (b)(6) 2023 and the back-out was discovered on the 6 week post-op images (b)(6) 2024.The device was ex-planted (b)(6) 2024 and it was discovered that both sliders (blocking mechanisms) had broken.The plate and screws were replaced.Immediate post-op images appear to be normal.The post-op image provided reveals one screw backed out approximately 6-7mm and some subsidence of the cage at the c7 superior endplate.The returned plate shows that both sliders are broken in the necked down area just next to the hammer-head portion that blocks the screw.It is unclear whether the sliders were damaged pre-operatively, inter-operatively or if they broke post-operatively.No determinations can be made as to the cause of the reported issue.

• Brand Name: RESONATE
• Common Device Name: RESONATE ANTERIOR CERVICAL PLATE, 3-LEVEL, 51MM
• 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: 18751470
• Report Number: 3004142400-2024-00035
• Device Sequence Number: 3703626
• Product Code: KWQ
• UDI-Device Identifier: 00193982155384
• UDI-Public: 00193982155384
• 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: 2023
• Device Explanted Year: 2024
• 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): 02/21/2024

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: 1194.3051
• Device Lot Number: ETB016XB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• 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