Ponto M52171Recalls & reported problems
Oticon Medical AB · Ponto BHX Implant, 4 mm, with abutment, 14 mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is an Oticon Medical Ponto BHX bone-anchored hearing implant that is surgically placed in the skull. Reports mostly describe the implant failing to fuse with the surrounding bone, and the device later coming loose or being removed, along with pain and skin irritation at the site. There are 30 reports, 27 injuries and no deaths, and 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
- 30
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 05712149009633), received between Oct 12, 2016 and Apr 16, 2026 — classified as 27 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (18 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 Osseointegrate18
- Loosening of Implant Not Related to Bone-Ingrowth5
- Osseointegration Problem2
- Patient Device Interaction Problem2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Microbial Contamination of Device1
Patient problems
- Inadequate Osseointegration21
- Implant Pain4
- Head Injury3
- Skin Infection3
- No Code Available2
- Skin Inflammation/ Irritation1
- Swelling/ Edema1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryApr 16, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryOct 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IMPLANT LOSS-ELECTIVE REMOVAL DUE TO MILD PAIN AND NON USE.
Patient problems: Implant Pain
MAUDE report 20358465 ↗InjurySep 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IMPLANT LOSS-ELECTIVE REMOVAL DUE TO DRAINAGE AND DISCOMFORT.
Patient problems: Implant Pain; Skin Infection
MAUDE report 20145202 ↗InjuryMay 16, 2024Osseointegration Problem; Osseointegration Problem
IMPLANT LOSS-INADEQUATE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 19331576 ↗InjuryApr 26, 2024Osseointegration Problem; Osseointegration Problem
InjuryNov 30, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 11, 2023Microbial Contamination of Device; Microbial Contamination of Device
InjuryJun 16, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IMPLANT LOSS-TRAUMA: PATIENT HIT HIS HEAD ON CAR DOOR.
Patient problems: Head Injury
MAUDE report 17141846 ↗InjuryApr 6, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
InjuryMar 24, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS-INADEQUATE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 13890183 ↗InjuryJul 19, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
InjuryJun 21, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
InjuryJun 21, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 23, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 15, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS.
Patient problems: Inadequate Osseointegration; Skin Inflammation/ Irritation; Swelling/ Edema
MAUDE report 11673482 ↗InjuryDec 22, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 10, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS THREE WEEKS AFTER SURGERY.
Patient problems: Inadequate Osseointegration
MAUDE report 10981607 ↗InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 27, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IMPLANT LOSS DUE TO TRAUMA - SWEATSHIRT GOT CAUGHT IN THE ABUTMENT AND PULLED THE IMPLANT OUT WHILE PATIENT WAS TAKING THE SWEATSHIRT OFF.
Patient problems: No Code Available
MAUDE report 8644082 ↗InjuryMay 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS - SPONTEANEOUS LOSS/INADEQUATE OSSEOINTEGRATION. PATIENT WOKE UP AND THE IMPLANT HAD FALLEN OUT.
Patient problems: Inadequate Osseointegration
MAUDE report 8585821 ↗InjuryMar 19, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS - INADEQUATE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 8431712 ↗InjuryJun 18, 2018Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT LOSS, IT WAS REPORTED THAT THE PATIENT HAD A POSSIBLE INFECTION AT THE IMPLANT SITE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 7608842 ↗InjuryFeb 5, 2018Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 5, 2018Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 5, 2018Failure 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 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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