MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO SCREWS

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that creo screws (2) have broken post operatively.This event occurred in (b)(6).

Manufacturer Narrative

The device was not available for evaluation as it remains in the patient.No determinations can be made as to the cause of the reported issue.

Manufacturer Narrative

The device was not available for evaluation as it remains in the patient.The imaging provided show that the two (2) screws have fractured at the screw shank at level l3.No determinations can be made as to the cause of the reported issue.

Event Description

It was reported that creo screws (2) have broken post operatively.This event occurred in germany.

• Brand Name: CREO
• Type of Device: CREO SCREWS
• 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 ; 6109301822
• MDR Report Key: 13095262
• MDR Text Key: 287526858
• Report Number: 3004142400-2021-00242
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2021
• 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