MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 8.5X80MM POLYAXIAL SCREW, COCR HEAD, TI SHANK

Model Number	5146.1882
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a screw head disassociated from the shank post-operatively.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.It was reported that a screw head disassociated from the shank post-operatively.The implant and x-rays were not provided for visual inspection, therefore no visual assessment of the implant or it's placement could be performed.The exact cause remains unknown due to the inability to evaluate the implant or the implants position, intraoperative conditions, or the root cause of the observed pain.

• Brand Name: CREO
• Common Device Name: CREO THREADED 8.5X80MM POLYAXIAL SCREW, COCR HEAD, TI SHANK
• 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: 18823382
• Report Number: 3004142400-2020-00020
• Device Sequence Number: 7214626
• Product Code: NKB
• UDI-Device Identifier: 00889095130522
• UDI-Public: 00889095130522
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 5146.1882
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown