Ponto M51138Recalls & reported problems
Oticon Medical AB · Wide implant, 4 mm, with abutment, 12 mm · Class 2 · Implant
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05712149003938), received between Oct 16, 2017 and Apr 3, 2025 — classified as 15 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (10 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 Osseointegrate10
- Loss of Osseointegration3
- Loosening of Implant Not Related to Bone-Ingrowth1
- Osseointegration Problem1
Patient problems
- Inadequate Osseointegration12
- Head Injury2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2025Loss of Osseointegration; Loss of Osseointegration
IMPLANT LOSS-SPONTANEOUS LOSS. NO INDICATION OF DEVICE MALFUNCTION.
Patient problems: Inadequate Osseointegration
MAUDE report 21761100 ↗InjuryNov 28, 2024Osseointegration Problem; Osseointegration Problem
InjuryApr 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
InjurySep 23, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS - INADEQUATE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 15474517 ↗InjuryJun 17, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 15, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS. ABUTMENT STUCK IN SHIRT.
Patient problems: Inadequate Osseointegration
MAUDE report 12810701 ↗InjuryMar 5, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 26, 2021Failure to Osseointegrate; Failure to Osseointegrate
PATIENT RAN HAND THROUGH HAIR AND NOTICED IMPLANT FELL OUT. NO OBVIOUS TRAUMA.
Patient problems: Inadequate Osseointegration
MAUDE report 11385158 ↗InjuryDec 10, 2020Loss of Osseointegration; Loss of Osseointegration
IMPLANT LOSS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10981608 ↗InjuryAug 18, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 20, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS A FEW WEEKS AFTER IMPLANTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 9605511 ↗InjuryDec 2, 2019Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 9, 2018Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 6, 2017Loss of Osseointegration; Loss of Osseointegration
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.