MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, EXTRA LORDOTIC, 3-LEVEL, 54MM

Model Number	1194.3154
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.It was reported that there was revision surgery was performed to remove a screw that backed out of the plate post operatively.It was a 3 level, extra lordotic, 54mm resonate plate at c3-6.The original surgery date was (b)(6) 2024.The revision date was (b)(6) 2024.X-ray images were provided.All the screws appear to be fully seated in the intra-op image.The post-op image shows one screw fully backed out of the plate.The sales rep reported that during the revision the screw migrated lateral to the plate while exposed and it could not be removed.The surgeon aborted the procedure without removing the screw and plans to refer to a general surgeon.The rep reported that the patient did not have pain.At the time of this report a surgery has not been scheduled for a general surgeon to remove the screw.Updates will be provided as more information becomes available.It is unclear whether some damage occurred to the plate or sliders inter-operatively or what the cause of the issue could have been.
Event or Problem Description
It was reported that a revision was needed to replace resonate screws backing out of the plate post-operatively.

• Brand Name: RESONATE
• Common Device Name: RESONATE ANTERIOR CERVICAL PLATE, EXTRA LORDOTIC, 3-LEVEL, 54MM
• 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: 20677696
• Report Number: 3004142400-2024-00267
• Device Sequence Number: 20931607
• Product Code: KWQ
• UDI-Device Identifier: 00193982155551
• UDI-Public: 00193982155551
• 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: 2024
• 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): 11/13/2024

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: 1194.3154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 11/13/2024
• 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