Ponto M51149Recalls & reported problems
Oticon Medical AB · Abutment, 12 mm · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05712149004027), received between Mar 1, 2022 and Jun 5, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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
- Failure to Osseointegrate1
- Patient Device Interaction Problem1
Patient problems
- Inadequate Osseointegration1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ABUTMENT REMOVED DUE TO PAINFUL RECURRENT IMPLANT SITE INFECTION.
Patient problems: Pain; Unspecified Infection
MAUDE report 22150138 ↗InjuryMar 1, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS: LOOSENING ABUTMENT SCREW LOOSENS THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 13631166 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.