Vitality® 07.02072.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024009943), received between Aug 28, 2019 and Jan 5, 2023 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT A VITALITY PROBE BROKE INTRA-OP; THE TIP WAS RECOVERED USING PLIERS. THERE WAS A DELAY OF 5 MINUTES WITHOUT PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102563 ↗
• InjuryDec 31, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A LENKE PROBE BROKE OFF IN THE PATIENT'S BONE INTRA-OPERATIVELY. THE SURGEON HAD TO DRILL OUT SOME OF THE PEDICLE BONE AROUND THE TIP IN ORDER TO REMOVE IT; IT WAS SUCCESSFULLY REMOVED.

  Patient problems: Spinal Column Injury

  MAUDE report 13125401 ↗
• InjuryJun 30, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON WAS USING A LENKE PROBE IN AN AGGRESSIVE MANNER INTRA-OPERATIVELY WHEN CREATING THE PATHWAY FOR A PEDICLE SCREW DUE TO THE PATIENT'S DIFFICULT ANATOMY AND HARD BONE WHEN THE TIP OF THE PROBE BROKE OFF. THE SURGEON CHOSE TO LEAVE THE PIECE IN PLACE SINCE IT WAS ENCASED IN THE BONY ANATOMY AND WOULD NOT AFFECT THE PATIENT. A DIFFERENT PROBE WAS USED TO COMPLETE THE SURGERY WITHOUT FURTHER PATIENT IMPACTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 12096617 ↗
• MalfunctionOct 15, 2020Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE SURGERY, THE PROBE BECAME BENT. WHILE ATTEMPTING TO STRAIGHTEN THE BENT PROBE ON THE BACK TABLE IN THE OR, THE TIP BROKE OFF. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10684628 ↗
• InjurySep 4, 2020Fracture; Difficult to Insert; Fracture; Difficult to Insert

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10495076 ↗
• MalfunctionAug 28, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A CURVED LENKE PROBE BROKE OFF AND BECAME STUCK IN THE PEDICLE DURING THE PROCEDURE. THE SURGEON WAS ABLE TO REMOVED THE STUCK PIECE WITHOUT INCIDENT OR PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8940510 ↗