MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. PROTEX; 6.0MM STRAIGHT ROD, 500MM

Model Number	109.521
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation as it remains in the patient.Possible causes for the rod fracture include pseudoarthrosis, excessive bending or contouring of the rod, or excessive in-vivo forces.These all may contribute to premature fatigue failure of the rods.The exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that a bilateral rod breakage occurred post-operatively.

• Brand Name: PROTEX
• Common Device Name: 6.0MM STRAIGHT ROD, 500MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 10504491
• Report Number: 3004142400-2020-00100
• Device Sequence Number: 13595990
• Product Code: MNH
• UDI-Device Identifier: 00889095034783
• UDI-Public: 00889095034783
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 09/03/2020

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: 109.521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other