MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVERE; REVERE 5.5MM CURVED ROD, 95MM

Model Number	124.695
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.Initial observation showed that the rod was fractured along with wear on the rod possibly from a rod holder.Imaging provided showed that the rod fracture occurred just superior to the patient's right l5 screw head.The fracture surface indicates a fatigue fracture, which is consistent with the rod being initially implanted in 2014.However, an exact cause to the reported issue could not be determined.
Event or Problem Description
It was reported there was a revision surgery to replace a revere rod that had broken post operatively, causing patient pain.

• Brand Name: REVERE
• Common Device Name: REVERE 5.5MM CURVED ROD, 95MM
• 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: 14321731
• Report Number: 3004142400-2022-00065
• Device Sequence Number: 4843483
• Product Code: MNH
• UDI-Device Identifier: 00849044001839
• UDI-Public: 00849044001839
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K061202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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): 04/26/2022

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: 124.695
• Device Lot Number: BGP064CG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2013
• 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 Age: 74 YR
• Patient Sex: Female
• Patient Weight: 96 KG
• Patient Race: White