MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO AMP THREADED POLYAXIAL TULIP

Model Number	1119.0110
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a creo amp threaded polyaxial tulip head has dissociated from the shank post operatively.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation.It was confirmed that the screws were assembled at the back table and that each screw head was locked.Bilateral reduction towers were used to reduce a low-grade spondylolisthesis at the l5-s1 level.It is possible that multiple factors, including the patient's obesity and high forces related to the reduction procedure at the level of the s1 screw head combined with the torque from the patient's reported twisting ultimately applied high forces on the screw construct that may have contributed to the dissociation of the right s1 screw head; however, no determinations could be made as to the cause of the reported issue.

• Brand Name: CREO
• Common Device Name: CREO AMP THREADED POLYAXIAL TULIP
• 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: 18837582
• Report Number: 3004142400-2023-00169
• Device Sequence Number: 7486390
• Product Code: MNH
• UDI-Device Identifier: 00889095059656
• UDI-Public: 00889095059656
• 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
• 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): 03/02/2024

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: 1119.0110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 03/05/2024
• 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 Age: 61 YR
• Patient Sex: Male