NA 389.55Recalls & reported problems
Synthes GmbH · ENDPLATE ELEVATOR 20MM WIDTH · Class 1
- 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 10705034775975), received between Nov 2, 2023 and Nov 2, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Material Integrity Problem1
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 2, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE HANDLE OF THE ENDPLATE ELEVATOR IN QUESTION BROKE. THERE WERE NO REPORTED PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN ENDPLATE ELEVATOR 20MM WIDTH. THIS IS REPORT 1 OF 1 FOR (B)(4) .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18057559 ↗
Other ELEVATOR devices
- NA 399.36Synthes GmbH · ELEVATOR15 reports
- NA 399.48Synthes GmbH · ELEVATOR15 reports
- NA 399.40Synthes GmbH · ELEVATOR9 reports
- NA 399.481Synthes GmbH · ELEVATOR8 reports
- NA 03.133.202Synthes GmbH · ELEVATOR3 reports
- NA 399.37Synthes GmbH · ELEVATOR3 reports
- NA 389.56Synthes GmbH · ELEVATOR2 reports
- Innomed, Inc. 3450Innomed, Inc. · Elevator2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.