MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, 1-LEVEL, 10MM

Model Number	1194.1010
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor any imaging was available for evaluation.Additional information provided from the revision surgery noted that the blocking mechanism was either broken or stuck in the open position.The screw at this location was removed; however, the remainder of the construct was left in place.The exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that a revision surgery was done due to a screw backing out of a resonate plate post-operatively.
Event or Problem Description
It was reported that a revision surgery was done due to a screw backing out of a resonate plate post-operatively.
Additional Manufacturer Narrative
Neither the device nor any imaging was available for evaluation.Additional information provided from the revision surgery noted that the blocking mechanism was either broken or stuck in the open position.The screw at this location was removed; however, the remainder of the construct was left in place.It has been confirmed that the surgeon did not seat the screw far enough intra-operatively.

• Brand Name: RESONATE
• Common Device Name: RESONATE ANTERIOR CERVICAL PLATE, 1-LEVEL, 10MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11890474
• Report Number: 3004142400-2021-00097
• Device Sequence Number: 19650621
• Product Code: KWQ
• UDI-Device Identifier: 00193982154233
• UDI-Public: 00193982154233
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/01/2021

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: 1194.1010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other