MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVERE; 6.5MM REVERE PEDICLE SCREW 45MM

Model Number	124.465
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that revision surgery was required to remove two revere pedicle screws due to non-union and loosening at l4.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The parts were not available for evaluation as they were retained by the patient.It's likely the screw loosening was caused by pseudarthrosis and/or poor bone quality.However, a definitive cause of the reported issue cannot be determined.

• Brand Name: REVERE
• Common Device Name: 6.5MM REVERE PEDICLE SCREW 45MM
• 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: 18831124
• Report Number: 3004142400-2019-00022
• Device Sequence Number: 14214841
• Product Code: MNH
• UDI-Device Identifier: 00849044001242
• UDI-Public: 00849044001242
• 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 Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 124.465
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/04/2024
• 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 Age: 45 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White