MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. FORTIFY CORPECTOMY SPACER; FORTIFY Ø20MM CORE, HEIGHT 62-92MM

Model Number	151.154
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a revision surgery it was found that a fortify ø20mm core had lost height 2 years post operatively.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation as it was discarded by the hospital.The post-operative imaging provided shows twelve visible threads above the 151.150.03 gear.No determinations could be made as to the cause of the reported issue.

• Brand Name: FORTIFY CORPECTOMY SPACER
• Common Device Name: FORTIFY Ø20MM CORE, HEIGHT 62-92MM
• 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: 18837731
• Report Number: 3004142400-2023-00111
• Device Sequence Number: 7415568
• Product Code: MQP
• UDI-Device Identifier: 00889095043068
• UDI-Public: 00889095043068
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K112756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 03/04/2024

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: 151.154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic