MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO MIS; CREO MIS MODULAR POLYAXIAL TULIP, 30MM REDUCTION

Model Number 1134.0100

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 03/06/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Neither the device or any imaging could be provided for evaluation.It is possible that a near maximum medial-lateral angle could cause the screw head to pull off when normalized to the rod because it could be outside of the range it was designed to be within.However, no determinations could be made as to the cause of the reported issue.

Event Description

It was reported that a creo mis modular polyaxial tulip popped off the shank during surgery and was left in the patient.

• Brand Name: CREO MIS
• Type of Device: CREO MIS MODULAR POLYAXIAL TULIP, 30MM REDUCTION
• 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: 18822026
• MDR Text Key: 336796616
• Report Number: 3004142400-2023-00046
• Device Sequence Number: 1
• Product Code: MNH
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1134.0100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2023
• 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