MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVERE; TRANS-FACET-SCREW INTERNAL SPINAL FIXATION SYSTEM, STERILE

Model Number	124.464
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was unavailable for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that the surgeon removed four loose screws and replaced with four ha coated screws.These were replaced with 4 ha screws in same length but in 7.5 diameter.The lock caps and 2 50mm rods were also removed and replaced with new.There was no adverse effect to the patient.The case was finished and all went well.
Additional Manufacturer Narrative
It was reported that a revision surgery had to be performed to take out four ø6.5mm revere pedicle screws due to screw loosening.They were replaced by four ø7.5mm ha-coated screws.The exact cause cannot be determined due to the parts not being returned.If the parts are returned in the future, further engineering evaluations will be performed, and this form will be updated if necessary.This risk is documented and within expected parameters and will continue to be monitored.The following sections were updated for this supplemental report: a1, a2, a3, a6, b4, g3, g6, h2, h6, h10.
Event or Problem Description
It was reported that the surgeon removed four loose screws and replaced with four ha coated screws.These were replaced with 4 ha screws in same length but in 7.5 diameter.The lock caps and 2 50mm rods were also removed and replaced with new.There was no adverse effect to the patient.The case was finished and all went well.

• Brand Name: REVERE
• Common Device Name: TRANS-FACET-SCREW INTERNAL SPINAL FIXATION SYSTEM, STERILE
• 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: 24434348
• Report Number: 3004142400-2026-00030
• Device Sequence Number: 21406891
• Product Code: MNH
• UDI-Device Identifier: 00849044001235
• UDI-Public: 00849044001235
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K061202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/23/2026

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: 124.464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/23/2026
• 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: 62 YR
• Patient Sex: Male
• Patient Race: White