Ponto M51137Recalls & reported problems
Oticon Medical AB · Wide implant, 4 mm, with abutment, 9 mm · Class 2 · Implant
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05712149003921), received between Oct 16, 2017 and Mar 20, 2026 — classified as 21 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (14 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 Osseointegrate14
- Loss of Osseointegration3
- Loosening of Implant Not Related to Bone-Ingrowth2
- Adverse Event Without Identified Device or Use Problem1
- Osseointegration Problem1
Patient problems
- Inadequate Osseointegration19
- Unspecified Infection2
- Head Injury1
- Pain1
- Skin Infection1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryMar 20, 2026Loss of Osseointegration
InjuryNov 6, 2025Loss of Osseointegration; Loss of Osseointegration
IMPLANT LOSS-SPONTANEOUS LOSS.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 23485081 ↗InjuryMay 16, 2024Osseointegration Problem; Osseointegration Problem
InjuryAug 11, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IMPLANT LOSS-SPONTANEOUS LOSS.
Patient problems: Inadequate Osseointegration; Skin Infection
MAUDE report 17511621 ↗InjuryNov 4, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 27, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS. INSUFFICIENT OSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 12232175 ↗InjuryAug 18, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 24, 2020Loss of Osseointegration; Loss of Osseointegration
InjuryDec 2, 2019Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 19, 2019Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 19, 2019Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 19, 2019Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 21, 2017Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 14, 2017Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 6, 2017Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 6, 2017Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 6, 2017Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS DURING AN ABUTMENT CHANGE.
Patient problems: Inadequate Osseointegration
MAUDE report 7002450 ↗InjuryOct 16, 2017Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS, INFECTION AT THE IMPLANT SITE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 6950722 ↗InjuryOct 16, 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.