MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. TRANSITION; TRANSITION ROD WITH CORD, STRAIGHT 150MM

Model Number	152.075S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.An image was provided showing two broken transition rod with cord, straight, 150mm implants which were removed.The rod portion of each transition implant was attached to a revere in-line connector.The end spool portion of the implant fractured between the cord grip and the rod.Upon revision, it was reported that the cord remained intact within the semi-rigid portion of the implant.No occurrence of patient trauma was reported.The product was not returned for evaluation and the exact cause of the reported issue cannot be determined.The following sections have been updated: b4, e1, e3, h2, h6, h10.
Event or Problem Description
It was reported that two transition rods with cords had broken and were removed.This was a t4 to pelvis case, where t4-5, ts-6, and t6-7 were transition.An inline connector was placed at tb and connected the transition to a 6.0 cobalt chrome rod.

• Brand Name: TRANSITION
• Common Device Name: TRANSITION ROD WITH CORD, STRAIGHT 150MM
• 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: 18825144
• Report Number: 3004142400-2018-00018
• Device Sequence Number: 2970350
• Product Code: NQP
• UDI-Device Identifier: 00849044023633
• UDI-Public: 00849044023633
• 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 Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 152.075S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 69 YR
• Patient Sex: Female
• Patient Race: White