MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; 5.5 MM CURVED ROD, TITANIUM ALLOY, 55MM LENGTH

Model Number 1119.7055

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.It was reported a creo rod became loose post-operatively.From the x-ray images the observed failure is consistent with destabilizing the construct by removing the novel interbody spacer and replacing it with the patients bone.The improperly installed cross connector and the unstable construct at l4/l5 is consisten with a destabilized construct imaparting in excessive torsional forces on the construct resulting in the dissociation of the rod from the screw.

Event Description

It was reported that a creo rod became loose post-operatively.

• Brand Name: CREO
• Type of Device: 5.5 MM CURVED ROD, TITANIUM ALLOY, 55MM LENGTH
• 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: 18823387
• MDR Text Key: 336809685
• Report Number: 3004142400-2020-00022
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095064742
• UDI-Public: 00889095064742
• 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: 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1119.7055
• Device Lot Number: BGV215EF
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR