MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, 2-LEVEL, 28MM

Model Number 1194.2028

Device Problem Device Slipped (1584)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/27/2021

Event Type  malfunction  

Manufacturer Narrative

Imaging provided shows the inferior screw has backed out anteriorly past the screw blocking mechanism.During implantation, it was noticed that both of the blocking mechanisms were broken off at the inferior level.Evaluation of the suspect device shows that it does not appear the "ceiling" above the blocking mechanism was damaged.It is possible that the blocking mechanism broke prior to the screw loosening and backing out of the plate, not able to provide any resistance for a loosening screw; however, the exact cause of the reported issue could not be determined.

Event Description

It was reported that a revision surgery was done for a screw which had backed out of a resonate plate post-operatively.

• Brand Name: RESONATE
• Type of Device: RESONATE ANTERIOR CERVICAL PLATE, 2-LEVEL, 28MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon 19403 ; 6109301800
• MDR Report Key: 11544522
• MDR Text Key: 259378091
• Report Number: 3004142400-2021-00051
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00193982154790
• UDI-Public: 00193982154790
• 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
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1194.2028
• Device Lot Number: ETW316CA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Date Manufacturer Received: 02/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR