MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, 2-LEVEL, 30MM

Model Number	1194.2030
Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.It was reported that there was revision surgery to remove a plate that had broken locking mechanisms.It was a 2 level, 20mm resonate plate at c3-5.The original surgery date is currently not known.The revision date was (b)(6) 2024.It was reported the patient was undergoing surgery for an adjacent level when the broken locking mechanisms were noticed.The surgeon proceeded to remove the plate and screws and did not replace them because fusion had already occurred at those levels.No adverse effect to the patient was reported.At the time of this report, x-rays are not available.Therefore it is unclear how much the screws were backing out.It was reported the surgeon's technique to implant the plate was to use the awl with sleeve and insert variable angle screws without drilling.Pictures of the ex-planted plate with broken sliders were provided.It is unclear whether some damage occurred to the plate or sliders inter-operatively or what the cause of the issue could have been.This evaluation determined that this failure was within expected risk; therefore, no further actions will be taken at this time.No determinations can be made for the cause of the reported issue at the moment.
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, 2-LEVEL, 30MM
• 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: 20610266
• Report Number: 3004142400-2024-00250
• Device Sequence Number: 20669135
• Product Code: KWQ
• UDI-Device Identifier: 00193982154813
• UDI-Public: 00193982154813
• 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 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): 11/04/2024

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: 1194.2030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 11/05/2024
• 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 Sex: Unknown