SYMPHONY 2020-33-335Recalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM TAP, STANDARD THREADS 3.5mm 0-50mm +/-0.75 percent · Class 2
All models of SYMPHONY (113)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034532578), received between Sep 10, 2024 and Sep 10, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Cut4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT ON UNKNOWN DATE IN 2024, THE TAPS WERE DULL AND UNABLE TO BE USED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A TAP 3.5MM STD THREAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20185235 ↗MalfunctionSep 10, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT ON UNKNOWN DATE IN 2024, THE TAPS WERE DULL AND UNABLE TO BE USED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A TAP 3.5MM STD THREAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20185164 ↗MalfunctionSep 10, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT ON UNKNOWN DATE IN 2024, THE TAPS WERE DULL AND UNABLE TO BE USED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A TAP 3.5MM STD THREAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20185040 ↗MalfunctionSep 10, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT ON UNKNOWN DATE IN 2024, THE TAPS WERE DULL AND UNABLE TO BE USED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A TAP 3.5MM STD THREAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20184984 ↗
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- VELYS 4515-70-106Depuy (Ireland) · Orthopedic stereotaxic instrument564 reports
- NA 209999Mako Surgical Corp. · Orthopedic stereotaxic instrument522 reports
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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