MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO STABILIZATION SYSTEM; CREO THREADED 9.5X80MM POLYAXIAL SCREW

Model Number	5119.1982
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device or any imaging could be provided for evaluation.It was reported that a driver tip fractured and remained stuck in the patient and a cut piece of rod was tightened to the screw head and used to try to remove the screw, resulting in the screw head disassociation from the screw post.Although the reported sequence of events contributed to the user attempting a rescue method, the screw is not designed to be removed by turning a rod tightened to the screw head.This may have resulted in excessive forces on the screw head causing dissociation from the screw post.
Event or Problem Description
It was reported that during a revision surgery the screw head of a creo threaded polyaxial screw popped off while it was being removed.It was left in the patient's body.This event occurred in japan.

• Brand Name: CREO STABILIZATION SYSTEM
• Common Device Name: CREO THREADED 9.5X80MM POLYAXIAL 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: 15978221
• Report Number: 3004142400-2022-00182
• Device Sequence Number: 12568842
• Product Code: MNH
• UDI-Device Identifier: 00889095106077
• UDI-Public: 00889095106077
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2022

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: 5119.1982
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 12/14/2022
• 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: Female
• Patient Race: Asian