MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 6.5X45MM POLYAXIAL SCREW

Model Number	5119.1647
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a creo rod became loose twenty-three days post-operatively.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The imaging provided shows a construct extending from l4-s1 with a rise lriterbody spacer at l4-5 and l5-s1 (one per level).The left l4 pedicle screw fs dislodged and displaced laterally from the rod; addilfonally, the l4-l5 rise interbody has rotated and a lateral listhesis can be observed between l4-l5.The anterior/posterior slice of ct imaging shows a vertebral body fracture between the endplates of the l4 vertebral body, biased towards the right side.It was reported during the initial surgery that the l4 left screw would slip back to its original position on the rod following compression and tight ening of the locking cap.The parts were not returned for evaluation as they were retained by the hospital.Desta bilization of the anterior spine by the vertebral body fracture may have placed excessive forces on the screw, dislodging if from the rod and allowing the l4 vertebral body to slip.In addition, dislodgement the screw from the rod may have destabilized the l4-l5 motion segment, placing excessive loads on the vertebral body and causing the observed fracture and listhesis.However, the exact cause of the reported issue could not be determined.

• Brand Name: CREO
• Common Device Name: CREO THREADED 6.5X45MM 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: 18823395
• Report Number: 3004142400-2020-00036
• Device Sequence Number: 7181174
• 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 Implanted Year: 2020
• Device Explanted Year: 2020
• 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: 5119.1647
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 03/02/2024
• 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: 35 YR
• Patient Sex: Female
• Patient Race: White