MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO ROD, PRODUCT CODE:

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/11/2019

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The creo rod was not available for evaluation as it remains in the patient.Evaluation of the anterior-posterior x-ray shows an l2-s1 construct with no pedicle screws at l4 due to a compressive fracture of the vertebral body, and a rise tlif interbody at l5-s1.The right rod is visibly fractured adjacent to the superior face of the l3 right screw.It's possible intraoperative damage to the rod during bending or manipulation, overload of the rod during cyclic loading, or a traumatic event may have contributed to the breakage.However, the exact cause of the reported issue cannot be determined at this time.

Event Description

It was reported that a creo rod broke 2.5 years post-operatively between l2/3 on the patient's right side.

• Brand Name: CREO
• Type of Device: CREO ROD, PRODUCT CODE:
• 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: 18828732
• MDR Text Key: 336806661
• Report Number: 3004142400-2019-00033
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/04/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Race: White