Pivot Guardian 3105000306Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327565379), received between Dec 28, 2022 and Dec 28, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2022Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE WAS PATIENT INJURY OF A BROKEN FEMUR THAT REQUIRED AN ADDITIONAL PROCEDURE TO REPAIR.

  Patient problems: Bone Fracture(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 16064480 ↗
• InjuryDec 28, 2022Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE WAS A PATIENT INJURY OF A BROKEN FEMUR.

  Patient problems: Bone Fracture(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 16064477 ↗
• InjuryDec 28, 2022Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE WAS A PATIENT INJURY OF A BLOWN OUT WALL OF THE PATIENT'S FEMUR.

  Patient problems: Hip Fracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16064388 ↗
• InjuryDec 28, 2022Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE WAS PATIENT INJURY OF A BROKEN FEMUR THAT REQUIRED AN ADDITIONAL PROCEDURE TO REPAIR.

  Patient problems: Hip Fracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16064387 ↗