Ponto M52169Recalls & reported problems
Oticon Medical AB · Ponto BHX Implant, 4 mm, with abutment, 9 mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Oticon Ponto bone conduction implant has 123 adverse event reports, with no deaths and 106 injuries. Most reports describe the implant failing to bond with bone or loosening, with some implants lost spontaneously, and a few mention infections. 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
- 124
- Deaths reported
- 0
- Injuries reported
- 107
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 05712149009619), received between Jun 29, 2016 and Sep 18, 2026 — classified as 107 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (76 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate76
- Loosening of Implant Not Related to Bone-Ingrowth16
- Appropriate Device Problem Term/Code Not Available8
- Osseointegration Problem7
- Patient Device Interaction Problem7
- Loss of Osseointegration6
- No Apparent Adverse Event3
- Extrusion1
Patient problems
- Inadequate Osseointegration90
- Head Injury12
- Pain10
- Unspecified Infection5
- Discomfort3
- Implant Pain3
- Injury3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 25 most recent of 124 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryApr 30, 2026Patient Device Interaction Problem
ACTIVATION WAS PERFORMED ON (B)(6) 2026, AND 3 DAYS LATER THE PATIENT CONTACTED THE HOSPITAL DUE TO SPONTANEOUS IMPLANT LOSS.
Patient problems: Aseptic loosening; Inadequate Osseointegration
MAUDE report 25043583 ↗InjuryApr 3, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryApr 2, 2026Patient Device Interaction Problem
InjuryMar 25, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryMar 20, 2026No Apparent Adverse Event
SENTIO EXPLANT-ELECTIVE REMOVAL DUE TO REPORTED LIMIT BENEFIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24647406 ↗InjuryDec 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
InjuryAug 19, 2025No Apparent Adverse Event; No Apparent Adverse Event
ABUTMENT REMOVAL: PATIENT HAS SINGLE SIDED DEAFNESS, TRANSITIONING TO COCHLEAR IMPLANT. NO INDICATION OF DEVICE MALFUNCTION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22838974 ↗InjuryJun 30, 2025Loss of Osseointegration; Loss of Osseointegration
IMPLANT LOSS-INADEQUATE OSSEOINTEGRATION. NO INDICATION OF DEVICE MALFUNCTION.
Patient problems: Inadequate Osseointegration
MAUDE report 22356219 ↗InjuryMay 15, 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 22027432 ↗InjuryApr 29, 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 21925466 ↗InjuryApr 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
InjuryMar 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
EXPLANT DUE TO PAIN AND PATIENT NOT PERCIEVING BENEFIT WITH DEVICE.
Patient problems: Implant Pain
MAUDE report 21652461 ↗InjuryDec 30, 2024No Apparent Adverse Event; No Apparent Adverse Event
EXPLANT DUE TO PATIENT NOT BEING HAPPY WITH HOW IT LOOKS. NO INDICATION OF DEVICE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21033829 ↗InjuryNov 28, 2024Osseointegration Problem; Osseointegration Problem
InjuryOct 17, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
WHEN THE SURGICAL DRAPE WAS REMOVED THE IMPLANT UNEXPECTEDLY DISLODGED FROM THE PATIENT SKULL.
Patient problems: Head Injury
MAUDE report 20469699 ↗InjuryOct 3, 2024Osseointegration Problem; Osseointegration Problem
IMPLANT LOSS-INADEQUATE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 20358474 ↗InjurySep 24, 2024Osseointegration Problem; Osseointegration Problem
IMPLANT LOSS-INADEQUATE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 20289778 ↗InjurySep 24, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
InjuryAug 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
ELECTIVE REMOVAL DUE TO PAIN AND NUMBNESS IN THE IMPLANT AREA.
Patient problems: Implant Pain
MAUDE report 20038598 ↗InjuryMay 3, 2024Osseointegration Problem; Osseointegration Problem
InjuryMay 3, 2024Osseointegration Problem; Osseointegration Problem
InjuryApr 26, 2024Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth; Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth
IMPLANT LOSS-SPONTANEOUS LOSS, INFECTION/INFLAMATION.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 19189966 ↗InjuryMar 21, 2024Osseointegration Problem; Osseointegration Problem
IMPLANT LOSS-INADEQUATE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 18949462 ↗InjuryFeb 29, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
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 M52170Oticon Medical AB · Hearing Aid, Bone Conduction, Implanted120 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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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