MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE EXTREME ANGLE ANTERIOR CERVICAL PLATE SYSTEM; RESONATE ANTERIOR CERVICAL PLATE, 3-LEVEL, 45MM

Model Number 1194.3045

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

It was reported that screws are backing out of the resonate plate post-operatively.

Manufacturer Narrative

The device was not available for evaluation as it remains in the patient.The imaging provided shows the screw head sticking out of the plate.It is possible that the screws were not fully seated in the screw hole during insertion; however, an exact cause of the reported issue could not be determined.

Manufacturer Narrative

The two screws that backed out of the plate were returned for evaluation.The imaging provided shows the screw head sticking out of the plate.It is possible that the screws were not fully seated in the screw hole during insertion; however, an exact cause of the reported issue could not be determined.

Event Description

It was reported that screws are backing out of the resonate plate post-operatively.

• Brand Name: RESONATE EXTREME ANGLE ANTERIOR CERVICAL PLATE SYSTEM
• Type of Device: RESONATE ANTERIOR CERVICAL PLATE, 3-LEVEL, 45MM
• 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: 14873581
• MDR Text Key: 303250059
• Report Number: 3004142400-2022-00102
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00193982155360
• UDI-Public: 00193982155360
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1194.3045
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male