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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2018

Event Type  malfunction  

Event Description

The screw head popped off from the screw shank.This wasn't noticed until it was seen on the post-operative x-ray which was taken for reasons unrelated to the screw separation.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The implant was not returned for evaluation as they remain in the patient.No determinations can be made as to the cause of the reported issue.The following sections have been updated: b4, e1, e3, h2, h6, h10.

• 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: 18815497
• MDR Text Key: 336629682
• Report Number: 3004142400-2018-00015
• 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: 02/29/2024

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: 02/15/2018
• 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: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American