MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO ADDITION MIS; Z ROD, TITANIUM ALLOY, 6.0 ROD, 12MM OFFSET, 100MM-200MM

Model Number 1175.2601

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Neither the device or any imaging were available for evaluation at this time.No determinations can be made as to the cause the reported issue.

Event Description

It was reported that the patient experienced a bilateral rod fracture approximately three months post-operatively.

• Brand Name: CREO ADDITION MIS
• Type of Device: Z ROD, TITANIUM ALLOY, 6.0 ROD, 12MM OFFSET, 100MM-200MM
• 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: 18817283
• MDR Text Key: 337349433
• Report Number: 3004142400-2019-00077
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180210
• 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: 1175.2601
• Date Manufacturer Received: 10/24/2019
• 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