MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO MIS; CREO MIS SCREW

Device Problems Collapse (1099); Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation as it remains in the patient.No determinations can be made as to the cause of the reported issue.

Event Description

It was reported that revision was done due to creo mis screw which loosened post operatively with subsequent cage collapse.This event occurred in (b)(6).

Manufacturer Narrative

The device was not available for evaluation as it remains in the patient.The imaging provided show screw migration relative to the superior vertebral body of the instrumented level, however the construct itself appears to remain rigidly assembled.However, no determinations can be made as to the cause of the reported issue.

Event Description

It was reported that revision was done due to creo mis screw which loosened and cage subsidence post-operatively.This event occurred in austria.

• Brand Name: CREO MIS
• Type of Device: CREO MIS SCREW
• 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: 13095179
• MDR Text Key: 286059073
• Report Number: 3004142400-2021-00243
• Device Sequence Number: 1
• Product Code: MNH
• 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,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• 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: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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