MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; 4.75MM CURVED ROD, COBALT CHROME, 70MM LENGTH

Model Number	7067.7070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery was performed to replace creo rods that were found broken post operatively.
Additional Manufacturer Narrative
The device was not available for evaluation.Our investigation of the returned images indicated that one of the rods was fractured in two pieces and the second rod was fractured at multiple locations.The original surgery completed in (b)(6) 2023 was a fusion from l3 to l5.X-ray imaging was taken after the patient complained of back pain.The surgeon reviewed the x-ray images on (b)(6) 2024 and reported observations of possible non-union and multiple fractures in both rods.The revision surgery was conducted on (b)(6) 2024 to replace the fractured rods which was completed without complications.X-ray images of the construct and optical images of the explanted rod fragments provided by the representative show damage to the construct that could be consistent with non-union.Because the parts were unavailable for evaluation and surgical conditions cannot be replicated, the exact cause of the rod fracture cannot be determined.The observed overall risk level is low, which matches the observed anticipated risk level; therefore, the overall risk of the system has been maintained.No determinations could be made as to the cause of the reported issue.

• Brand Name: CREO
• Common Device Name: 4.75MM CURVED ROD, COBALT CHROME, 70MM 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: 20161241
• Report Number: 3004142400-2024-00196
• Device Sequence Number: 7313360
• Product Code: MNH
• UDI-Device Identifier: 00889095196252
• UDI-Public: 00889095196252
• 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: 2023
• Device Explanted Year: 2024
• 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): 09/06/2024

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: 7067.7070
• Device Lot Number: JNY233DD/JNY118GD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2021
• 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: Male