Ponto M52170Recalls & reported problems
Oticon Medical AB · Ponto BHX Implant, 4 mm, with abutment, 12 mm · Class 2 · Implant
Quick summary
This Oticon Medical Ponto bone-anchored hearing implant has 120 adverse event reports, with 106 injuries and no deaths. Most describe the implant failing to bond with the skull bone, and some describe the implant being lost after head trauma. Reports fell from 13 in the prior 12 months to 2 in the last 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 120
- Deaths reported
- 0
- Injuries reported
- 106
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 05712149009626), received between Jun 28, 2016 and Feb 20, 2026 — classified as 106 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (77 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 Osseointegrate77
- Loosening of Implant Not Related to Bone-Ingrowth15
- Osseointegration Problem8
- Loss of Osseointegration6
- Patient Device Interaction Problem6
- Appropriate Device Problem Term/Code Not Available4
- No Apparent Adverse Event4
- Connection Problem1
Patient problems
- Inadequate Osseointegration92
- Head Injury19
- Unspecified Infection8
- Pain5
- Implant Pain3
- No Code Available2
- Skin Disorders2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 120 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryJan 7, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjurySep 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
InjuryJun 13, 2025No Apparent Adverse Event; No Apparent Adverse Event
ABUTMENT WAS REMOVED DUE TO SKIN OVERGROWTH. NO NEW ABUTMENT TO BE APPLIED BECAUSE PATIENT IS DUE TO HAVE A COCHLEAR IMPLANT.
Patient problems: Skin Disorders
MAUDE report 22201820 ↗InjuryJun 13, 2025Loss of Osseointegration; Loss of Osseointegration
IMPLANT LOSS-INADEQUATE OSSEOINTEGRATION. NO INDICATION OF DEVICE MALFUNCTION.
Patient problems: Inadequate Osseointegration
MAUDE report 22201515 ↗InjuryJun 5, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
InjuryJun 5, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IMPLANT LOSS-INADEQUATE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22148551 ↗InjuryMay 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
InjuryMay 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IMPLANT LOSS-INADEQUATE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22085064 ↗InjuryApr 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ABUTMENT REMOVED DUE TO PAINFUL RECURRENT IMPLANT SITE INFECTION.
Patient problems: Pain; Unspecified Infection
MAUDE report 21899713 ↗InjuryFeb 20, 2025No Apparent Adverse Event; No Apparent Adverse Event
ABUTMENT WAS REMOVED DUE TO SKIN INFLAMATION. NO INDICATION OF DEVICE MALFUNCTION.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 21420506 ↗InjuryJan 23, 2025No Apparent Adverse Event; No Apparent Adverse Event
THE PATIENT KNOCKED THE IMPLANT OUT WHILE HAVING A NIGHTMARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21216762 ↗InjuryJan 23, 2025No Apparent Adverse Event; No Apparent Adverse Event
IMPLANT LOSS-INADEQUATE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 21216761 ↗InjuryNov 28, 2024Osseointegration Problem; Osseointegration Problem
InjuryNov 20, 2024Osseointegration Problem; Osseointegration Problem
IMPLANT LOSS-INADEQUATE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 20732203 ↗InjuryOct 3, 2024Osseointegration Problem; Osseointegration Problem
InjurySep 5, 2024Osseointegration Problem; Osseointegration Problem
InjuryAug 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
InjuryJul 17, 2024Osseointegration Problem; Osseointegration Problem
InjuryJun 4, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IMPLANT LOSS-INADEQUATE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 19456820 ↗InjuryMay 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
ELECTIVE REMOVAL DUE TO PAIN AND SKIN IRRITATION
Patient problems: Implant Pain
MAUDE report 19237014 ↗InjuryApr 26, 2024Osseointegration Problem; Osseointegration Problem
InjuryMar 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryMar 21, 2024Osseointegration Problem; Osseointegration Problem
InjuryFeb 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IMPLANT LOSS-ELECTIVE REMOVAL DUE TO PAIN ISSUES.
Patient problems: Implant Pain; Skin Infection
MAUDE report 18757583 ↗
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
- Baha 93335Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted81 reports
- Baha 93334Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted61 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.