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

Model Number 1134.0010

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2023

Event Type  malfunction  

Event Description

It was reported that revision surgery was needed to replace (2) creo mis locking caps that were found loosened three months post operatively.

Manufacturer Narrative

The device could not be returned for evaluation.The imaging provided shows the l4 and l5 locking caps separated from the screw on a l4-l5 construct.No determinations could be made as to the cause of the reported issue.

• Brand Name: CREO MIS STABILIZATION SYSTEM
• Type of Device: CREO MIS LOCKING CAP
• 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 ; 6109301800
• MDR Report Key: 16481579
• MDR Text Key: 310730430
• Report Number: 3004142400-2023-00023
• 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: K124058
• 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: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1134.0010
• Device Lot Number: BAA656AC
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2022
• 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