Ponto M52166Recalls & reported problems
Oticon Medical AB · Ponto BHX Implant, 3 mm, with abutment, 6 mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05712149009589), received between Nov 6, 2017 and Apr 16, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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
- Loosening of Implant Not Related to Bone-Ingrowth2
- Patient Device Interaction Problem2
- Failure to Osseointegrate1
Patient problems
- Inadequate Osseointegration2
- Skin Disorders2
- No Code Available1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryApr 16, 2026Patient Device Interaction Problem
ABUTMENT REMOVAL DUE TO RECURRENT SKIN OVERGROWTH.
Patient problems: Skin Disorders
MAUDE report 24895942 ↗InjuryMar 6, 2026Patient Device Interaction Problem
ABUTMENT REMOVAL DUE TO RECURRENT INFECTION / SKIN OVERGROWTH.
Patient problems: Skin Disorders
MAUDE report 24530863 ↗InjuryApr 3, 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 21761099 ↗InjuryMar 14, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IMPLANT LOSS - SPONTANEOUS LOSS. THE IMPLANT JUST FELT LOOSE AND SPONTANEOUSLY RELEASED AFTER LONG PERIIMPLANT INFECTION WITH MANY VISITS AND INTERVENTIONS TO HEAL.
Patient problems: No Code Available
MAUDE report 8419833 ↗InjuryNov 6, 2017Failure to Osseointegrate; Failure to Osseointegrate
PARENT HIT ABUTMENT/IMPLANT SITE WITH ELBOW. IMPLANT LOSS.
Patient problems: Inadequate Osseointegration
MAUDE report 7002426 ↗
Other Hearing Aid, Bone Conduction, Implanted devices
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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