MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. TRANSITION STABILIZATION SYSTEM; TRANSITION SCREW

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Date 05/11/2021

Event Type  malfunction  

Event Description

It was reported that a revision surgery was completed to remove loose transition screws at l1 that caused patient pain.

Manufacturer Narrative

Neither the device or any imaging could be provided for evaluation.Screw loosening is a known inherent risk of this device.

• Brand Name: TRANSITION STABILIZATION SYSTEM
• Type of Device: TRANSITION SCREW
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 12569380
• MDR Text Key: 281128989
• Report Number: 3004142400-2021-00187
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other