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

Model Number	109.521
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that post-operative imaging showed a rod breakage in the lower thoracic spine.Revision surgery was performed to remove the broken rod.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Four separate rods were returned for evaluation, indicating that the rods broke bilaterally.The fracture surfaces of all the rods is consistent with fatigue fracture.There are some gouges and scratches along each rod but only minor scratches in the area of the fracture.It was observed that all of the rods have been bent in multiple locations.One of the possible risks associated with pedicle screw systems is device component fracture.No x-rays images could be provided and therefore the construct itself could not be evaluated.These rods were used in a deformity construct and were subject to high stres s.It was stated that the fracture occurred in the lower thoracic spine which is in the area of the thoracolumbar junction.This junction is a natural transition from the mobfle lumbar spine to the relatively immobile thoracic spine.This transition also results in high stress concentrations.Additionally, all of the rods were observed to have multiple bends.Bending plastically deforms the rod and can lead to notching which can create a stress riser and affect the fatigue strength of the rod.It's possible that excessive rod bendlngf contouring, or excessive in-vivo forces contributed to the reported issue.However, the exact cause of the rod breakage cannot be determined.

• Brand Name: PROTEX
• Common Device Name: 6.0MM STRAIGHT ROD, 500MM
• 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: 18817066
• Report Number: 3004142400-2019-00075
• Device Sequence Number: 14580864
• Product Code: MNH
• UDI-Device Identifier: 00889095034783
• UDI-Public: 00889095034783
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K052069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 109.521
• Device Lot Number: CWU218AE
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2017
• 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 Sex: Unknown