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

Model Number 1134.0010

Device Problems Unintended Movement (3026); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 10/06/2021

Event Type  malfunction  

Event Description

It was reported that a revision surgery was completed due to creo mis locking caps that loosened post operatively, causing rise cage to migrate posteriorly.

Manufacturer Narrative

Imaging provided shows one locking cap has loosened at l4 and possibly two at s1.One rise implant was returned damaged with the drive screw separated from the implant.This appears to have happened during removal as all imaging received shows the implant to be fully intact.An exact cause of the reported issue cannot be determined.

• 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 ; 6109301822
• MDR Report Key: 12747684
• MDR Text Key: 282630001
• Report Number: 3004142400-2021-00213
• 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: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• 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: 10/07/2021
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White