VITALITY® 709M8550Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304868366), received between Oct 3, 2024 and Mar 24, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2025Fracture; Fracture

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

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21679756 ↗
• InjuryFeb 19, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ONE YEAR POST-OPERATIVELY, A PATIENT PRESENTED WITH WORSENING PAIN AND PSEUDOARTHROSIS AT L2-3 AND L5-S1 WITH LOOSE SCREWS BILATERALLY AT S1 AND AT LEFT L2. A REVISION SURGERY WAS PERFORMED WHERE THE SCREWS WERE REMOVED. THE L2 SCREW WAS REPLACED WITH A LARGER DIAMETER SCREW. THE SCREWS COULD NOT BE REPLACED AT S1; INSTEAD, THEY WERE MOVED TO ILIAC BILATERALLY. THIS IS REPORT TWO OF THREE FOR THIS EVENT.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21410543 ↗
• InjuryFeb 19, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ONE YEAR POST-OPERATIVELY, A PATIENT PRESENTED WITH WORSENING PAIN AND PSEUDOARTHROSIS AT L2-3 AND L5-S1 WITH LOOSE SCREWS BILATERALLY AT S1 AND AT LEFT L2. A REVISION SURGERY WAS PERFORMED WHERE THE SCREWS WERE REMOVED. THE L2 SCREW WAS REPLACED WITH A LARGER DIAMETER SCREW. THE SCREWS COULD NOT BE REPLACED AT S1; INSTEAD THEY WERE MOVED TO ILIAC BILATERALLY. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21410542 ↗
• InjuryOct 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO REPLACE TWO VITALITY SCREWS THAT FRACTURED DURING A CAR ACCIDENT. THE PATIENT WAS EXPERIENCING PAIN, AND THE SCREWS WERE REMOVED AND REPLACED WITH LARGER SCREWS AT THE S1 VERTEBRA. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 20363572 ↗