Ponto M51136Recalls & reported problems
Oticon Medical AB · Wide implant, 4 mm, with abutment, 6mm · 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 05712149003914), received between Nov 6, 2017 and Nov 28, 2024 — 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
- Osseointegration Problem1
Patient problems
- Inadequate Osseointegration2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 28, 2024Osseointegration Problem; Osseointegration Problem
IMPLANT LOSS-SPONTANEOUS LOSS DURING ABUTMENT CHANGE.
Patient problems: Inadequate Osseointegration
MAUDE report 20805247 ↗InjuryNov 6, 2017Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS. PRIMARY STABILITY WAS NOT ACHIEVED AT TIME OF SURGERY. IMPLANT FELL OUT SPONTANEOUSLY.
Patient problems: Inadequate Osseointegration
MAUDE report 7002499 ↗
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- Ponto M52169Oticon Medical AB · Hearing Aid, Bone Conduction, Implanted124 reports
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- Baha 93335Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted81 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.