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NA 04.615.525Recalls & reported problems

Synthes GmbH · 4.0MM TI ROD 80MM · Class 2 · Implant

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 10705034740621), received between Jan 29, 2020 and Jan 29, 2020 — 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.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 29, 2020Break; Break

    THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. THIS EVENT IS NOT A COMPLAINT AS THE REPORTED DEVICES WERE PARTS FROM THE FIELD RETURNED. THEY WERE TAGGED AS BROKEN BUT THESE WERE ACTUALLY REMNANTS OF IMPLANTS WHICH WERE CUT DURING THE SURGERY.

    Patient problems: No Patient Involvement

    MAUDE report 9643879 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.