MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. COALITION MIS; COALITION MIS ANCHOR, 12MM

Model Number 1136.2012

Device Problems Difficult to Remove (1528); Malposition of Device (2616)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

The device was not available for evaluation as it was discarded by the hospital.Additional information provided after the first anchor was deployed, the spacer was deemed to be in an appropriate position.The second anchor was deployed and it was discovered that the spacer had moved roughly 5mm posteriorly and the patient had lost motor function.The surgeon decided to perform a corpectomy to remove the implants.It is possible that the causes could be related to surgical technique, implant sizing, or another unknown issue; however, the exact cause of the reported issue could not be determined.

Event Description

It was reported that 2 coalition mis anchors were advanced too far causing the patient to lose motors.The anchors were unable to be retrieved with the removal tool, resulting in the surgeon performing a corpectomy to remove the cage and screws.

• Brand Name: COALITION MIS
• Type of Device: COALITION MIS ANCHOR, 12MM
• 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: 11226786
• MDR Text Key: 228604856
• Report Number: 3004142400-2021-00011
• Device Sequence Number: 1
• Product Code: OVE
• UDI-Device Identifier: 00889095358940
• UDI-Public: 00889095358940
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151939
• 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: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1136.2012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2020
• 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
• Patient Age: 53 YR