MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 5.5X35MM POLYAXIAL SCREW

Model Number	5119.1537
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not available for evaluation.Additional information provided that the patient had poor bone quality.It is possible the bone was unable to endure the physical stress during the insertion of the pedicle screws resulting in a fracture.There was no failure of the hardware used for fixation.
Event or Problem Description
It was reported by a representative from (b)(6) that a revision surgery was done due to a t8 vertebrae fracture and subsequent screw pulling out post-operatively.

• Brand Name: CREO
• Common Device Name: CREO THREADED 5.5X35MM POLYAXIAL SCREW
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11396178
• Report Number: 3004142400-2021-00034
• Device Sequence Number: 4275163
• Product Code: MNH
• UDI-Device Identifier: 00889095103526
• UDI-Public: 00889095103526
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5119.1537
• Device Lot Number: BAU611RG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 03/01/2021
• 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