Skip to content

ASCENT LE 66-2020Recalls & reported problems

Orthofix US LLC · 3.0MM TO 5.5MM TRANSITION ROD, 200MM X 200MM, ASCENT LE POCT · 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 18257200018765), received between Aug 11, 2017 and Aug 11, 2017 — 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

  • Failure of Implant1
  • No Code Available1

Recent adverse event reports

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

  • MalfunctionAug 11, 2017Break

    BASED ON THE INFORMATION PROVIDED, TWO TRANSITION RODS BROKE IN SITU RESULTING IN A REVISION SURGERY.

    Patient problems: Failure of Implant; No Code Available

    MAUDE report 6788246 ↗

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.