MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; 5.5MM HEX - ENDED ROD, COBALT CHROME, 500MM LENGTH

Model Number	7119.6500
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation as it remains in the patient.Evaluation of the two year follow-up anteriorposterior and lateral x-rays showed a t10-pelvis construct.No fracture could be visibly confirmed.The post-operative revision anteriorposterior x-ray showed the addition of satellite rods connected to the primary rod with rod-to-rod connectors between l1 and l2, and between s1 and the iliac offset connectors.The two month follow-up anteriorposterior x-ray found a visible opening of a gap in the right primary rod between l5 and s1.The broken rod was not removed and replaced, but bridged by the connectors and a long segment of rod.This potentially decreased the stiffness of the construct across l5-s1.This could have contributed to the observed separation of the fracture surface.However, an exact cause of the reported issue cannot be determined.
Event or Problem Description
It was reported that the patient experienced a rod breakage two years post-operatively requiring revision.During revision, adjacent satellite rods were added to reinforce the construct without removing the broken rod.During two month post-operative follow-up, a gap in the recently corrected construct was identified.The patient is experiencing coronal imbalance again and complaining of pain.

• Brand Name: CREO
• Common Device Name: 5.5MM HEX - ENDED ROD, COBALT CHROME, 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: 18832591
• Report Number: 3004142400-2019-00025
• Device Sequence Number: 7485701
• Product Code: MNH
• UDI-Device Identifier: 00889095197754
• UDI-Public: 00889095197754
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

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
• Device Model Number: 7119.6500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Ethnicity: Hispanic