MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. FORTIFY; FORTIFY Ø20MM CORE, HEIGHT 26-34MM

Model Number	151.151
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause of the reported issue could not yet be determined.
Event or Problem Description
It was reported by a representative from (b)(6) that a revision surgery was completed due to a fortify implant and screws which dislocated post-operatively.
Event or Problem Description
It was reported by a representative from germany that a revision surgery was completed due to a fortify implant and screws which dislocated post-operatively.
Additional Manufacturer Narrative
The device was not available as it remains in the patient.The imaging provided shows that the implant had subsided and shifted and the pedicle screws had lost purchase.Additional information provided that the surgeon believes this is likely due to poor bone quality.However, the exact cause of the reported issue could not be determined.

• Brand Name: FORTIFY
• Common Device Name: FORTIFY Ø20MM CORE, HEIGHT 26-34MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 12181111
• Report Number: 3004142400-2021-00136
• Device Sequence Number: 16949538
• Product Code: MQP
• UDI-Device Identifier: 00889095043037
• UDI-Public: 00889095043037
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D140943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 151.151
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 08/13/2021
• 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
• Patient Age: 74 YR