MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO AMP 4.5X45MM MODULAR CANNULATED SCREW

Model Number 1067.4345

Device Problem Fracture (1260)

Patient Problem Vertebral Fracture (4520)

Event Date 10/19/2020

Event Type  Injury  

Manufacturer Narrative

The device could not be provided for evaluation.No determinations can be made as to the cause of the reported issue.

Event Description

It was reported that a device related vertebral fracture occurred post-operatively.A revision surgery is scheduled.

Event Description

It was reported that a revision surgery was done due to a device related vertebral fracture occurred post-operatively.

Manufacturer Narrative

The device could not be returned for evaluation.Based on the imaging provided, it appears that no hardware has fractured.Additional information provided that the surgeon believes the cause of the l1 fracture was unbalanced fixation force between the upper and lower area.

• Brand Name: CREO
• Type of Device: CREO AMP 4.5X45MM MODULAR CANNULATED SCREW
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 10762225
• MDR Text Key: 213870187
• Report Number: 3004142400-2020-00139
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095023114
• UDI-Public: 00889095023114
• Combination Product (y/n): N
• PMA/PMN Number: K124058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1067.4345
• Device Lot Number: BAU539AE/BAV488YE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR