N/A 3602102Recalls & reported problems
Medtronic Sofamor Danek, Inc. · FEELER 3602102 PEDICLE 1.5MM · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169699977), received between Jul 9, 2024 and Feb 13, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE FEELER BROKE OFF WHEN OPENING A TRAY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21372423 ↗MalfunctionJul 9, 2024Break; Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A FEELER. IT WAS REPORTED THAT THE TIP BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19699650 ↗
Other TAP, BONE devices
- NA 311.43Synthes GmbH · TAP, BONE176 reports
- NA 311.01Synthes GmbH · TAP, BONE106 reports
- NA 311.431Synthes GmbH · TAP, BONE70 reports
- NA 03.424.124Synthes GmbH · TAP, BONE1 recall7 reports
- N/A 876-474Medtronic Sofamor Danek, Inc. · TAP, BONE1 recall0 reports
- NA 03.424.126Synthes GmbH · TAP, BONE1 recall0 reports
- A.L.P.S.® 8241-50-170Biomet Orthopedics, LLC · TAP, BONE1 recall0 reports
- NA 311.44Synthes GmbH · TAP, BONE41 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.