MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVERE STABILIZATION SYSTEM; 5.5MM STRAIGHT ROD, HEX-END, 300MM

Model Number	524.519
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither device or any imaging could be provided for evaluation.Post-operative rod breakage is a known risk of this device.
Event or Problem Description
It was reported by a representative from colombia that revision was completed due a revere rod breakage post operatively.

• Brand Name: REVERE STABILIZATION SYSTEM
• Common Device Name: 5.5MM STRAIGHT ROD, HEX-END, 300MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 12576760
• Report Number: 3004142400-2021-00180
• Device Sequence Number: 1205053
• Product Code: MNH
• UDI-Device Identifier: 00849044008050
• UDI-Public: 00849044008050
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D090145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 09/10/2021

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: 524.519
• Device Lot Number: BGS119BC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 10/05/2021
• 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