MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; Ø4.2MM BONE SCREW, VARIABLE ANGLE, SELF-DRILLING, 16MM

Model Number	1194.7216
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
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.
Additional Manufacturer Narrative
The device was unavailable for evaluation.It was reported that a revision surgery was needed to replace a screw that backed out of the bottom level of a 3 level extra lordotic resonate plate at c4-c7 post-operatively, on (b)(6) 2024.The sales rep reported the locking mechanism was broken and screw backed out.The exact date of the original surgery is currently unknown although the sales rep reported it was less than 1 year prior to the revision.The rep reported that there was no adverse effect to the patient.The surgeon replaced it with the same size plate and 4.6x16mm, variable angle, self-drilling rescue screws.No images are currently available.The screws do not appear to be damaged.They are slightly worn where they came in contact with the plate and/or sliders.No determinations can be made for the cause of the reported issue.

• Brand Name: RESONATE
• Common Device Name: Ø4.2MM BONE SCREW, VARIABLE ANGLE, SELF-DRILLING, 16MM
• 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: 19734433
• Report Number: 3004142400-2024-00154
• Device Sequence Number: 7062440
• Product Code: KWQ
• UDI-Device Identifier: 00193982152765
• UDI-Public: 00193982152765
• 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): 07/12/2024

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: 1194.7216
• Device Lot Number: BAB912VD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 61 YR
• Patient Sex: Male