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

Model Number 1134.0010

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation.Imaging provided shows at least one locking cap has completely disengaged from the screw head.No determinations can be made as to the cause of the reported issue.

Event Description

It was reported that a revision surgery was done because two locking caps at l4 had post-operatively popped off tulip bilaterally.

• Brand Name: CREO MIS
• Type of Device: CREO MIS LOCKING CAP
• 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: 12161039
• MDR Text Key: 263413472
• Report Number: 3004142400-2021-00126
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095071139
• UDI-Public: 00889095071139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D201515
• 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: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1134.0010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2021
• 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