MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ASSURE ANTERIOR CERVICAL PLATE SYSTEM

Model Number	110.354
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an assure plate had loosened post operatively.This event occurred in (b)(6).
Additional Manufacturer Narrative
Neither device or any imaging could be provided for evaluation.No determinations can be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision surgery was completed due to an assure plate being loose post operatively.This event occurred in italy.
Additional Manufacturer Narrative
Neither device or any imaging could be provided for evaluation.No determinations can be made as to the cause of the reported issue.

• Brand Name: ASSURE ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: CERVICAL PLATE
• 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 ; 6109301822
• MDR Report Key: 12844956
• Report Number: 3004142400-2021-00230
• Device Sequence Number: 4830104
• Product Code: KWQ
• UDI-Device Identifier: 00849044093124
• UDI-Public: 00849044093124
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D066562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 12/01/2021

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: 110.354
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown