Ponto M52167Recalls & reported problems
Oticon Medical AB · Ponto BHX Implant, 3 mm, with abutment, 9 mm · Class 2 · Implant
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05712149009596), received between Nov 14, 2016 and May 3, 2024 — classified as 11 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (7 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate7
- Osseointegration Problem3
- Loosening of Implant Not Related to Bone-Ingrowth2
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration10
- Head Injury3
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryMay 3, 2024Osseointegration Problem; Osseointegration Problem
InjuryApr 26, 2024Osseointegration Problem; Osseointegration Problem
InjuryMar 21, 2024Osseointegration Problem; Osseointegration Problem
IMPLANT LOSS-INADEQUATE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 18949383 ↗InjuryOct 18, 2023Failure to Osseointegrate; Loosening of Implant Not Related to Bone-Ingrowth; Failure to Osseointegrate; Loosening of Implant Not Related to Bone-Ingrowth
IMPLANT LOSS-TRAUMA/LOSS OF OSSEOINTEGRATION.
Patient problems: Head Injury; Inadequate Osseointegration
MAUDE report 17956016 ↗InjuryJan 27, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS-INADEQUATE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 16252055 ↗InjuryDec 30, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS-INADEQUATE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 16077739 ↗InjuryOct 21, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
InjuryAug 18, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 18, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 2, 2018Loss of Osseointegration; Loss of Osseointegration
InjuryDec 14, 2017Failure to Osseointegrate; Failure to Osseointegrate
Nov 14, 2016Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT/ABUTMENT SPONTANEOUSLY EXTRUDED.
Patient problems: Inadequate Osseointegration
MAUDE report 6099061 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.