MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED REDUCTION SCREW

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2022

Event Type  malfunction  

Event Description

It was reported that a revision surgery was needed for creo threaded reduction screw that broke post operatively.This event occurred in belgium.

Manufacturer Narrative

Neither the device or any imaging could be provided for evaluation.No determinations can be made as to the cause of the reported issue.

Manufacturer Narrative

Imaging could not be provided for evaluation.Additional information provided that during the revision surgery, the surgeon noticed that the reduction screw was not holding (screw to bone interface) so he replaced the creo reduction threaded screws with creo threaded ha screws.No determinations could be made as to the cause of the reported issue.

Event Description

It was reported that a revision surgery was needed for creo threaded reduction screw that broke post operatively.This event occurred in belgium.

• Brand Name: CREO
• Type of Device: CREO THREADED REDUCTION 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: 14884257
• MDR Text Key: 302846795
• Report Number: 3004142400-2022-00109
• 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
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/01/2022
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 07/29/2022
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian