MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, 3-LEVEL, 48MM

Model Number	1194.3048
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was unavailable for evaluation.It was reported that a screw backed out past the locking mechanism at the bottom level of a 3 level resonate plate at c4-c7.The original surgery date was (b)(6) 2024.The back-out was discovered on 6 week follow up images, (b)(6) 2024.Images were provided by the sales rep.The screws appear to be fully seated in the intra-op image.The 6 week post-op images shows several millimeters of at least one screw being proud of the plate at the bottom level.The sales rep reported there was negligible adverse effect to the patient and there are no plans for a revision at this time.No determinations can be made for the cause of the reported issue.
Event or Problem Description
It was reported that resonate screws are backing out of the plate 6 weeks post-operatively.
Additional Manufacturer Narrative
The device was unavailable for evaluation.It was reported that a screw backed out past the locking mechanism at the bottom level of a 3 level resonate plate at c4-c7.The original surgery date was 05/01/2024.The back-out was discovered on 6 week follow up images, on (b)(6) 2024.Images were provided by the sales rep.The screws appear to be fully seated in the intra-op image.The 6 week post-op images shows several millimeters of at least one screw being proud of the plate at the bottom level.The sales rep reported there was negligible adverse effect to the patient and there are no plans for a revision at this time.No determinations can be made for the cause of the reported issue.It was reported that a revision surgery was needed to remove two screws that backed out past the locking mechanism at the bottom level of a 3 level resonate plate at c4-c7.The original surgery date was on (b)(6) 2024.The screw back out was reported when it was first discovered on 6 week follow up images, on (b)(6) 2024.At that time there were negligible adverse effects to the patient and no plans for a revision.Sometime later the surgeon decided to revise and remove the screws.It was reported that the plate is still in the patient and the two removed screws were thrown away.The x-ray image provided showed the two screws partially backed out from the plate at the bottom level and a small piece of something next to them.A photo of a broken piece of a blocking mechanism which the surgeon removed was also provided.The patient was reported to be asymptomatic.It was also reported that the patient was not compliant in wearing a collar as the surgeon suggested and the patient has erratic instances of shaking their head back and forth, which may have contributed to the issue.The overall observed risk level would equate to a medium risk level.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.The following sections were updated in this report: b4, d4, g6, h2, h10.
Event or Problem Description
It was reported that a revision surgery was needed to replace screws that backed out of a resonate plate post-operatively.

• Brand Name: RESONATE
• Common Device Name: RESONATE ANTERIOR CERVICAL PLATE, 3-LEVEL, 48MM
• 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: 19776845
• Report Number: 3004142400-2024-00149
• Device Sequence Number: 15560695
• Product Code: KWQ
• UDI-Device Identifier: 00193982155377
• UDI-Public: 00193982155377
• 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,Followup
• Report Date (Section B): 09/25/2024

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: 1194.3048
• Device Lot Number: AXA683NB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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: Female