MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REFLECT; REFLECT CORD

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/12/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the subject device shows significant fraying at the breakage locations.Imprints were visible where the set screws were clamped onto the cords.This is a non-fusion device; therefore, subject to loading and motion stresses throughout its lifetime.Failure fatigue is a known risk of growth modulative devices.

Event Description

It was reported by a representative from the uk that the distal cords have broken post-operatively, and a revision surgery was completed to remove.

• Brand Name: REFLECT
• Type of Device: REFLECT CORD
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon 19403 ; 6109301800
• MDR Report Key: 11867068
• MDR Text Key: 255144986
• Report Number: 3004142400-2021-00095
• Device Sequence Number: 1
• Product Code: QHP
• 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: 05/19/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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