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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Fall (1848)

Event Type  Injury  

Manufacturer Narrative

The device was not available for evaluation as it remains in the patient.The imaging provided shows that each rod appears to no longer be retained in its respective superior most tulip.It is likely that the post-operative fall was the cause of the reported issue.

Event Description

It was reported that a revision surgery was done for two rods which had pulled out of the screw heads post-operatively due to a patient fall.

• Brand Name: CREO MIS
• Type of Device: CREO MIS TULIP
• 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: 10793114
• MDR Text Key: 214821166
• Report Number: 3004142400-2020-00150
• 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
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2020
• 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: 73 YR