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

Model Number	124.465
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revere pedicle screw was found fractured post-operatively.This occurred in south africa.
Additional Manufacturer Narrative
Based on the information provided, the patient underwent an l3-l5 transforaminal lumbar interbody fusion on (b)(6) 2024 with screws, rods, and intervertebral cages.The number or type of cage(s) placed was not provided.The patient complained of backpain at a follow-up on (b)(6) 2025 and underwent a ct scan on (b)(6) 2025.The ct report indicates confirmation of a "minimally displaced fracture of the neck of the right pedicular screw of the l5 vertebra, with mild angulation." it also notes the patient has a lumbosacral transitional vertebra with sacralization of l5.The report did not mention anything about fusion status at any level.The images provided appear to show an interbody cage in the l4/l5 disc space.It cannot definitively be determined if there is a cage at l3/l4.The status of fusion achieved at either level is also unclear.The images also do not show the screw head or screw neck area of the l5 screw.Moreover, no parts were returned with this complaint, therefore, the reported fracture cannot be confirmed, and the exact findings and cause cannot be determined.The part was manufactured in 2024.A review of the lot's dhr shows that the devices were manufactured to specification and all documentation and certificates of compliance were provided.This risk is documented and within expected parameters and will continue to be monitored.This complaint will be re-evaluated if parts are returned or additional information is provided at a future date.The following sections were updated for this supplemental report: b4, e1, e2, e3, g3, g6, h2, h6, h10.
Event or Problem Description
It was reported that the patient underwent a l3-l5 transforaminal lumbar interbody fusion (tlif) on (b)(6) 2024.She came for a follow-up on (b)(6) 2025 reporting backpain.Ct lumbar spine demonstrated fracture of the neck of the right l5 pedicle screw.Ct lumbar spine was performed on (b)(6) 2025.This event occurred in namibia.

• Brand Name: REVERE® STABILIZATION SYSTEM
• 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: 22676947
• Report Number: 3004142400-2025-00147
• Device Sequence Number: 9565600
• Product Code: MNH
• UDI-Device Identifier: 00849044001242
• UDI-Public: 00849044001242
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: WA
• PMA/510(K) Number: K061202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 124.465
• Device Lot Number: BAC0CBEV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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