MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; 5.5MM CURVED ROD, TITANIUM ALLOW, 70 MM LENGTH

Model Number	1119.7070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The rods were both inspected and all applicable dimensions were determined to be within specification.Excessive force placed on the spine and/or non-union may have contributed to the reported issue.The exact cause of the rod breakages could not be determined.
Event or Problem Description
A revision surgery was performed for an extension of an adjacent level.Once access was made, it was discovered that two creo rods were broken.Images taken prior to this did not show the breakages.

• Brand Name: CREO
• Common Device Name: 5.5MM CURVED ROD, TITANIUM ALLOW, 70 MM 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: 18825355
• Report Number: 3004142400-2018-00023
• Device Sequence Number: 7935343
• Product Code: MNH
• UDI-Device Identifier: 00889095064773
• UDI-Public: 00889095064773
• 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: 2015
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2024

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
• Operator of Device: Health Professional
• Device Model Number: 1119.7070
• Device Lot Number: BGD190HD, BGS013DD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (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 Age: 48 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White