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

Model Number	1067.4345
Health Effect - Clinical Code	Vertebral Fracture (4520)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device could not be provided for evaluation.No determinations can be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a device related vertebral fracture occurred post-operatively.A revision surgery is scheduled.
Event or Problem Description
It was reported that a revision surgery was done due to a device related vertebral fracture occurred post-operatively.
Additional 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
• Common Device Name: CREO AMP 4.5X45MM MODULAR CANNULATED SCREW
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 10762225
• Report Number: 3004142400-2020-00139
• Device Sequence Number: 14286888
• Product Code: MNH
• UDI-Device Identifier: 00889095023114
• UDI-Public: 00889095023114
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1067.4345
• Device Lot Number: BAU539AE/BAV488YE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR