MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 6.5 X 45MM POLYAXIAL SCREW

Model Number	5119 .1647
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery was required due to a loosened screw which showed haloing.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Evaluation of the provided imaging shows a slight lucency around the l4 pedicle screw.It was noted during the revision surgery that the patient had poor bone quality which necessitated additional decompression and extension of the construct to l2 and the pelvis with iliac screws.The device was not available for evaluation as it was retained by the hospital.It's possible poor bone quality or disrupted anatomy from the lateral screws may have contributed to the observed loosening.The creo stabilization system is contraindicated for severe osteoporosis, which may prevent adequate fixation, and for prior fusion at the levels to be treated.However, the exact cause of the reported issue cannot be determined.

• Brand Name: CREO
• Common Device Name: CREO THREADED 6.5 X 45MM 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: 18830965
• Report Number: 3004142400-2019-00021
• Device Sequence Number: 12732368
• Product Code: MNH
• UDI-Device Identifier: 00889095104158
• UDI-Public: 00889095104158
• 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 Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

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
• Device Model Number: 5119 .1647
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 49 YR
• Patient Sex: Male
• Patient Race: White