MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. TRANSITION STABILIZATION SYSTEM; TRANSITION ROD WITH CORD

Model Number	152.082
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was a revision surgery to replace transition rods that had broken post operatively.This event occurred in austria.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.Initial observation of the first construct shows cord breakage between the spools at l3 and l4, and the observation of the second construct shows cord breakage between the spools at l2 and l3.It is likely that excess forces from the patient's car accident caused the bilateral cord breaks; however, an exact cause of the reported issue could not be determined.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.Initial observation of the first construct shows cord breakage between the spools at l3 and l4, and the observation of the second construct shows cord breakage between the spools at l2 and l3.It is likely that excess forces from the patient's car accident caused the bilateral cord breaks; however, an exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported there was a revision surgery to replace transition rods that had broken post operatively.This event occurred in austria.

• Brand Name: TRANSITION STABILIZATION SYSTEM
• Common Device Name: TRANSITION ROD WITH CORD
• 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: 18834177
• Report Number: 3004142400-2023-00056
• Device Sequence Number: 12574204
• Product Code: NQP
• UDI-Device Identifier: 00849044023688
• UDI-Public: 00849044023688
• 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: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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: 152.082
• Device Lot Number: VPS037AD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2015
• 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: 50 YR
• Patient Sex: Unknown