Ponto M52168Recalls & reported problems
Oticon Medical AB · Ponto BHX Implant, 4 mm, with abutment, 6mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05712149009602), received between Nov 6, 2017 and Feb 20, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (4 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate4
- No Apparent Adverse Event1
Patient problems
- Inadequate Osseointegration4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2025No Apparent Adverse Event; No Apparent Adverse Event
ABUTMENT EXTRUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21420505 ↗InjuryFeb 17, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS-INADEQUATE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 16395343 ↗InjuryFeb 5, 2020Failure to Osseointegrate; Failure to Osseointegrate
THE IMPLANT HAS BECOME LOOSE AND WILL BE EXPLANTED, DATE OF EXPLANTATION NOT YET SET.
Patient problems: Inadequate Osseointegration
MAUDE report 9670449 ↗InjuryDec 22, 2017Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 6, 2017Failure to Osseointegrate; Failure to Osseointegrate
Other Hearing Aid, Bone Conduction, Implanted devices
- Baha 93331Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted446 reports
- Baha 93332Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted376 reports
- Baha 93550Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted371 reports
- Baha 93330Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted269 reports
- Baha 93338Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted128 reports
- Ponto M52169Oticon Medical AB · Hearing Aid, Bone Conduction, Implanted124 reports
- Ponto M52170Oticon Medical AB · Hearing Aid, Bone Conduction, Implanted120 reports
- Baha 93335Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted81 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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