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

Model Number 1119.0010

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation as it remains in the patient.The imaging provided shows the original l4/l5 construct, with the l4 left side locking cap migrated out of a screw head.No determinations could be made as to the cause of the reported issue.

Event Description

It was reported that a creo threaded locking cap was found loose 4 months post operatively.This event occurred in germany.

Event Description

It was reported that a revision surgery was performed for a creo threaded locking cap that was found loose at 4 months post operatively.This event occurred in germany.

Manufacturer Narrative

Imaging provided shows the migration of a locking cap.No determinations could be made as to the cause of the reported issue.The following sections have been updated: b3, b5, b6, b7, d6a, d6b, g6, h3, h10.

• Brand Name: CREO STABILIZATION SYSTEM
• Type of Device: CREO THREADED 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: 15851201
• MDR Text Key: 304828713
• Report Number: 3004142400-2022-00179
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095059496
• UDI-Public: 00889095059496
• 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,Followup
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1119.0010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2022
• 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
• Patient Age: 76 YR
• Patient Sex: Female