MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO AMP 4.5X40MM MODULAR CANNULATED SCREW

Model Number	1067.4340
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The two screws placed at t10 were found to be bending at the proximal end of the screw 1-year post-op.At the next follow-up 2-years after the operation, the two screws at t10 were found to be fractured at the proximal end of the screws.The surgeon has decided to not remove the fractured screw shanks as they are embedded in bone.Therefore, the implants were not returned for evaluation.The observed overall risk is low, which does not exceed the observed anticipated risk level; therefore, the overall risk of the system has been maintained and there is no further investigation required.Due to the inability to replicate surgical conditions and the forces experienced by the screws post-op, the exact cause of the failure cannot be determined at this time.
Event or Problem Description
It was reported that creo amp screws were found broken post operatively. .

• Brand Name: CREO
• Common Device Name: CREO AMP 4.5X40MM MODULAR CANNULATED SCREW
• 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: 21413370
• Report Number: 3004142400-2025-00032
• Device Sequence Number: 8317432
• Product Code: MNH
• UDI-Device Identifier: 00889095023107
• UDI-Public: 00889095023107
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2025

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: 1067.4340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/19/2025
• 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: Unknown