MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. COALITION MIS; COALITION MIS ANCHOR, 11MM

Model Number 1136.2011

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation.Post-operative imaging provided shows the spacers are too deep posteriorly, and the anchor is backing out.However, an exact cause of the reported issue cannot be determined.

Event Description

It was reported that a revision surgery was done to replace a coalition mis anchor dislodged with spacer subsidence 3 months post-operatively.

• Brand Name: COALITION MIS
• Type of Device: COALITION MIS ANCHOR, 11MM
• 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 ; 6109301822
• MDR Report Key: 12760258
• MDR Text Key: 285992021
• Report Number: 3004142400-2021-00210
• Device Sequence Number: 1
• Product Code: ODP
• UDI-Device Identifier: 00889095389999
• UDI-Public: 00889095389999
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D321550
• 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: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1136.2011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: No
• 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