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

Model Number	1120.1500
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that (2) creo 6.0mm straight rods were found broken bilaterally post operatively.
Additional 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
• Common Device Name: 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
• Report Number: 3004142400-2022-00137
• Device Sequence Number: 18023097
• Product Code: MNH
• UDI-Device Identifier: 00889095067453
• UDI-Public: 00889095067453
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1120.1500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female