MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. FORTIFY; FORTIFY Ø12MM CORE, HEIGHT 25-37MM

Model Number 151.053

Device Problems Collapse (1099); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

Imaging provided shows the lock post dislodged from the locked position.Evaluation of the subject device shows the lock geometry and the lock pocket to appear undamaged.The exact cause of the reported issue could not be determined.

Event Description

It was reported that a revision surgery was done due to a fortify 12mm core collapsing post-operatively.

• Brand Name: FORTIFY
• Type of Device: FORTIFY Ø12MM CORE, HEIGHT 25-37MM
• 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: 11778769
• MDR Text Key: 251660036
• Report Number: 3004142400-2021-00085
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00889095042917
• UDI-Public: 00889095042917
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112756
• 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: 05/04/2021

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: 151.053
• Device Lot Number: BAX462SH
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 05/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2020
• 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