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

Model Number	109.521
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the part nor any imaging was available for evaluation.According to information provided, the patient had 2 previous spine surgeries that failed, a laminectomy at l2/3 in (b)(6) 2011, and a laminectomy from l3-l5 in (b)(6) 2014.The protex rods in question was placed in (b)(6) 2018 as part of a bilateral construct from t3-pelvis.A signature peek spacer was placed at l2-l3, a lateral peek spacer at l3-l4 and l4-l5, and bilateral rise spacers at l5-s1.Creo pedicle screws were utilized from t4-pelvis and creo offset hooks at t3.It was also noted that based on the x-rays taken in (b)(6) 2023 and (b)(6) 2023, the rod was fractured before a fall in summer 2023.Since no parts were returned and no images provided, no determination could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision was completed for a protex rod that was found broken in the patient post operatively. .

• 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: 18888338
• Report Number: 3004142400-2024-00046
• Device Sequence Number: 3038063
• 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: 2018
• Device Explanted Year: 2024
• 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): 03/12/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 03/12/2024
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Race: White