MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. TRANSITION STABILIZATION SYSTEM; TRANSITION 7.5MM MIS HA POLYAXIAL PEDICLE SCREW, 50MM

Model Number	152.776S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
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 a revision occurred due to a transition screw being found broken post-operatively, it was removed and replaced.
Additional Manufacturer Narrative
Based on the information provided, the patient underwent surgery at l3-l5 with screws, rods, and intervertebral cages placements.The type of cage(s) placed was not provided.The report did not mention anything about fusion status at any level.X-rays and cts are provided based on patient's follow-up on (b)(6) 2025.X-ray images on (b)(6) 2025 are also provided.By comparing the lateral x-ray images before and at follow-up, they indicate the shank breakage of the left l3 pedicle screw.The ap x-ray images also confirm the screw fracture.The axial ct slice image indicates the detailed location of the screw breakage, which is around the middle of the screw shank.The images provided appear to show an interbody cage in the l3/l4 and l4/l5 disc spaces.The status of fusion achieved at either level is also unclear.No parts were returned with this complaint; therefore, the exact findings and cause cannot be determined.A risk reconciliation was performed with current risk management documentation.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 number of expected device uses in the past year is calculated based on the unit sold of transition stabilization system screws.The following sections were updated for this supplemental report: b4, b6, e1, e2, e3, g3, g6, h3, h6, h10.
Event or Problem Description
It was reported that a revision occurred due to a transition screw being found broken post-operatively, it was removed and replaced.

• Brand Name: TRANSITION STABILIZATION SYSTEM
• Common Device Name: TRANSITION 7.5MM MIS HA POLYAXIAL PEDICLE SCREW, 50MM
• 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: 23170189
• Report Number: 3004142400-2025-00211
• Device Sequence Number: 15664622
• Product Code: NQP
• UDI-Device Identifier: 00849044084368
• UDI-Public: 00849044084368
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K073439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 10/30/2025

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: 152.776S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 10/30/2025
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 90 KG