MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; 6.0MM STRAIGHT ROD, TITANIUM ALLOY, 500MM LENGTH

Model Number 1120.1500

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

It was reported that (2) creo 6.0mm straight rods were found broken bilaterally post operatively.

Manufacturer Narrative

The device was not available for evaluation as it remains in the patient.The imaging provided shows that the rods had fractured bilaterally at the l5/s1 level.The damage seen in the images can be consistent with a non-union.It is possible there was never adequate fusion and the forces from the original deformity correction were excessive at the distal level of the construct.The lack of fusion may cause the life cycle of the construct to be accelerated.It was reported that the rods were bent in conformance in order to achieve the correction.There was likely no notches or deformations to the rod that could have weakened it; however, this could not be confirmed as the original surgery took place years prior.No determinations could be made as to the cause of the reported issue.

• Brand Name: CREO
• Type of Device: 6.0MM STRAIGHT ROD, TITANIUM ALLOY, 500MM 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: 15426448
• MDR Text Key: 300590394
• Report Number: 3004142400-2022-00137
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095067453
• UDI-Public: 00889095067453
• 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: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1120.1500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2022
• 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 Sex: Female