MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. FORTIFY; FORTIFY-R Ø14MM CORE, HEIGHT 28-40MM

Model Number	351.051
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that revision was needed to replace a fortify spacer that deviated post-operatively.This event occurred in sweden.
Additional Manufacturer Narrative
The device was not available for evaluation.No determinations could be made as to the cause of the reported issue.
Additional Manufacturer Narrative
The implant was returned for evaluation.The tav portion of the superior end plate has separated from the implant.The separation of the end plate was due to the retainment pins shearing due to some unknown force.The dhr shows these pins were within the listed material and heat spec.The surgeon did not use any supplemental fixation, posterior or otherwise.The ous insert for this device shows that all cages are indicated to be used in conjunction with supplemental fixation.The lack of supplemental fixation does not give insight into the ultimate cause of the cage failure.However, the decrease in stability throughout the patient's spine as a result of a lack of supplemental fixation would create a much higher load on the cage than a typical one would see.Even with the increased loading, it is not possible to determine the ultimate reason for failure, as no information was present about the patient's activities or the state of the cage during the revision surgery.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that revision was needed to replace a fortify spacer that deviated post-operatively.This event occurred in sweden.

• Brand Name: FORTIFY
• Common Device Name: FORTIFY-R Ø14MM CORE, HEIGHT 28-40MM
• 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: 20516236
• Report Number: 3004142400-2024-00214
• Device Sequence Number: 20972086
• Product Code: MQP
• UDI-Device Identifier: 00889095217285
• UDI-Public: 00889095217285
• 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: 2024
• Device Explanted Year: 2024
• 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): 11/21/2024

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: 351.051
• Device Lot Number: BAB8C5CM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• 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: 69 YR
• Patient Sex: Male
• Patient Race: White