MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REFLECT; REFLECT 4.0MM CORD WITH COLLET, 250MM

Model Number 1140.1250S

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation as it remains in the patient.This device is subject to loading and motion stresses throughout its lifetime.Fatigue failure is a known risk of growth modulative devices.It is possible that the implant was damaged at the time of implantation, causing premature failure of the device.It is also possible that a single initial breakage caused a change in load or forces experienced by the construct, leading to subsequent failure at the adjacent level.

Event Description

It was reported by a representative from greece that the distal cords at l1-l2 and l2-l3 have broken post-operatively.A revision surgery has not been scheduled.

• Brand Name: REFLECT
• Type of Device: REFLECT 4.0MM CORD WITH COLLET, 250MM
• 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: 11348601
• MDR Text Key: 234209829
• Report Number: 3004142400-2021-00036
• 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: 02/15/2021

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
• Device Model Number: 1140.1250S
• Device Lot Number: GBV198HB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2018
• 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 Age: 14 YR
• Patient Weight: 45