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

Model Number 5119.1647

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2020

Event Type  malfunction  

Event Description

It was reported a creo rod became loose twenty-three days post-operatively.

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
• Type of Device: 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
• MDR Text Key: 336874125
• Report Number: 3004142400-2020-00036
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095104158
• UDI-Public: 00889095104158
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5119.1647
• Date Manufacturer Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Race: White