SYMPHONY 2020-00-158Recalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM PEDICLE PROBE, STRAIGHT 3.2mm 0-40 mm +/- 2 percent · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034531021), received between Nov 11, 2025 and Nov 11, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2025Break; Material Deformation; Break; Material Deformation
WHEN USING THE PEDICLE FINDER IN A PATIENT, THE 3.2 PEDICLE PROBE BENT. WHEN THE USER TRIED TO STRAIGHTEN IT, THE PROBE SNAPPED AT THE TIP. THERE WAS A MINIMAL DELAY TO SURGERY. CURRENTLY, THERE ARE NO KNOWN ADVERSE CONSEQUENCES FOR THE PATIENT. ITEM HAS BEEN DISPOSED OF BY HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23525129 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.