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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Neither the parts or any imaging are available at this time.No determination as to the cause of the reported issue could be made.

Event Description

It was reported by a patient that two creo rod fractures occurred post-opera tively.The first fracture at left l3-4 idenunea at o year and ten months, the second fracture at right l3-4 identified at two years and ten months.The patient stated she was rear ended in a motor vehicle accident with an impact of 30-40mph approximately one year and five months following her initial surgery.Follow ing this accident, imaging showed a t1 compression fracture; however, nothing was noted at that lime regardin the fractured rods.

• Brand Name: CREO
• Type of Device: CREO ROD
• 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: 18823393
• MDR Text Key: 336808056
• Report Number: 3004142400-2020-00033
• 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
• Report Date: 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 03/23/2020
• 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: Female