Baha 93338Recalls & reported problems

Summary

The FDA's MAUDE database contains 128 adverse event reports that list this exact device (DI 09321502033442), received between Aug 1, 2017 and Apr 15, 2026 — classified as 128 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (48 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 128 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE ABUTMENT SITE. THE PATIENT SUBSEQUENTLY UNDERWENT REVISION SURGERY ON (B)(6) 2025 UNDER LOCAL ANESTHESIA TO EXCISE THE SKIN. HOWEVER, THE ISSUE COULD NOT BE RESOLVED SO THE PATIENT UNDERWENT ABUTMENT REMOVAL PROCEDURE AND A NEW BAHA CONNECT SYSTEM WAS IMPLANTED MORE SUPERIORLY IN AN AREA WITH LESS FATTY TISSUE UNDER GENERAL ANESTHESIA ON (B)(6) 2026.

  Patient problems: Impaired Healing

  MAUDE report 24880755 ↗
• InjuryApr 15, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE ABUTMENT SITE. THE PATIENT SUBSEQUENTLY UNDERWENT REVISION SURGERY ON (B)(6) 2025 UNDER LOCAL ANESTHESIA TO EXCISE THE SKIN. HOWEVER, THE ISSUE COULD NOT BE RESOLVED SO THE PATIENT UNDERWENT ABUTMENT REMOVAL PROCEDURE AND A NEW BAHA CONNECT SYSTEM WAS IMPLANTED MORE SUPERIORLY IN AN AREA WITH LESS FATTY TISSUE UNDER GENERAL ANESTHESIA ON (B)(6) 2026.

  Patient problems: Impaired Healing

  MAUDE report 24880754 ↗
• InjuryMar 11, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN ISSUES WITH GRANULATION TISSUE AT THE ABUTMENT SITE AND OTORRHEA. SUBSEQUENTLY, THE PATIENT UNDERWENT A SKIN REVISION SURGERY OF TREATMENT WITH SILVER NITRATE ON (B)(6) 2025.

  Patient problems: Fluid Discharge; Impaired Healing

  MAUDE report 24566293 ↗
• InjuryMar 11, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN ISSUES WITH GRANULATION TISSUE AT THE ABUTMENT SITE AND OTORRHEA. SUBSEQUENTLY, THE PATIENT UNDERWENT A SKIN REVISION SURGERY OF TREATMENT WITH SILVER NITRATE ON (B)(6) 2025.

  Patient problems: Fluid Discharge; Impaired Healing

  MAUDE report 24566292 ↗
• InjuryMar 9, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN ISSUES AROUND ABUTMENT SITE (SPECIFIC DATE NOT REPORTED). THE PATIENT UNDERWENT REVISION SURGERY TO DEBRIDE THE AFFECTED SITE ON JUNE 10, 2025. DURING THE SAME PROCEDURE ON (B)(6) 2025, THE PATIENT ALSO RECEIVED A STEROID INJECTION (DURATION NOT REPORTED). LATER, THE PATIENT DEVELOPED BLEEDING AT ABUTMENT SITE. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24542350 ↗
• InjuryMar 9, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN ISSUES AROUND ABUTMENT SITE (SPECIFIC DATE NOT REPORTED). THE PATIENT UNDERWENT REVISION SURGERY TO DEBRIDE THE AFFECTED SITE ON (B)(6) 2025. DURING THE SAME PROCEDURE ON (B)(6) 2025, THE PATIENT ALSO RECEIVED A STEROID INJECTION (DURATION NOT REPORTED). LATER, THE PATIENT DEVELOPED BLEEDING AT ABUTMENT SITE. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24542349 ↗
• InjuryFeb 26, 2026Loss of Osseointegration

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE AND ABUTMENT LOSS (SPECIFIC DATE NOT REPORTED). A REVISION SURGERY IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24451521 ↗
• InjuryFeb 25, 2026Loss of Osseointegration

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE AND ABUTMENT LOSS (SPECIFIC DATE NOT REPORTED). A REVISION SURGERY IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24449951 ↗
• InjuryFeb 6, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE IMPLANT SITE, REQUIRING USE OF A LONGER ABUTMENT. THE ORIGINAL ABUTMENT WAS REPORTEDLY LOST FOLLOWING A PATIENT FALL, DURING WHICH THE ABUTMENT DETACHED AND THE FIXATION SCREW FRACTURED. ON (B)(6) 2025, THE PATIENT UNDERWENT REVISION SURGERY UNDER GENERAL ANESTHESIA. DURING THE PROCEDURE, IT WAS OBSERVED THAT PART OF THE ABUTMENT THREAD REMAINED STUCK WITHIN THE IMPLANT SCREW, AND THE SURGEON WAS UNABLE TO REMOVE THE REMAINING ABUTMENT THREAD OUT OF IMPLANT. SUBSEQUENTLY, ON (B)(6) 2025, A FURTHER SURGICAL PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA, DURING WHICH THE ABUTMENT WAS REPLACED. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Impaired Healing

  MAUDE report 24277247 ↗
• InjuryFeb 6, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE IMPLANT SITE, REQUIRING USE OF A LONGER ABUTMENT. THE ORIGINAL ABUTMENT WAS REPORTEDLY LOST FOLLOWING A PATIENT FALL, DURING WHICH THE ABUTMENT DETACHED AND THE FIXATION SCREW FRACTURED. ON (B)(6) 2025, THE PATIENT UNDERWENT REVISION SURGERY UNDER GENERAL ANESTHESIA. DURING THE PROCEDURE, IT WAS OBSERVED THAT PART OF THE ABUTMENT THREAD REMAINED STUCK WITHIN THE IMPLANT SCREW, AND THE SURGEON WAS UNABLE TO REMOVE THE REMAINING ABUTMENT THREAD OUT OF IMPLANT. SUBSEQUENTLY, ON (B)(6) 2025, A FURTHER SURGICAL PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA, DURING WHICH THE ABUTMENT WAS REPLACED. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Impaired Healing

  MAUDE report 24277243 ↗
• InjuryJan 21, 2026Detachment of Device or Device Component; Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT SUBSEQUENT TO SUSTAINING AN IMPACT TO THE ABUTMENT SIDE OF THE HEAD. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED UNDER A GENERAL ANAESTHETIC ON (B)(6) 2025. THE PATIENT WAS REIMPLANTED WITH A TRANSCUTANEOUS OSIA IMPLANT SYSTEM AT A NEW SITE.

  Patient problems: Head Injury

  MAUDE report 24127878 ↗
• InjuryJan 21, 2026Detachment of Device or Device Component; Therapeutic or Diagnostic Output Failure

  PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT SUBSEQUENT TO SUSTAINING AN IMPACT TO THE ABUTMENT SIDE OF THE HEAD. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED UNDER A GENERAL ANAESTHETIC ON (B)(6) 2025. THE PATIENT WAS REIMPLANTED WITH A TRANSCUTANEOUS OSIA IMPLANT SYSTEM AT A NEW SITE.

  Patient problems: Head Injury

  MAUDE report 24127874 ↗
• InjuryJan 14, 2026Loss of Osseointegration

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANT SITE AND WAS SUBSEQUENTLY TREATED WITH ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). THE EVENT RESULTED IN FIXTURE LOSS AND LOSS OF OSSEOINTEGRATION WITH MINOR BLEEDING. THE PATIENT DOES NOT WISH TO UNDERGO REIMPLANTATION AND WILL BECOME A NON-USER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Inadequate Osseointegration; Skin Infection

  MAUDE report 24065295 ↗
• InjuryJan 14, 2026Loss of Osseointegration

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANT SITE AND WAS SUBSEQUENTLY TREATED WITH ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). THE EVENT RESULTED IN FIXTURE LOSS AND LOSS OF OSSEOINTEGRATION WITH MINOR BLEEDING. THE PATIENT DOES NOT WISH TO UNDERGO REIMPLANTATION AND WILL BECOME A NON-USER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Inadequate Osseointegration; Skin Infection

  MAUDE report 24065293 ↗
• InjuryDec 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS FOR THE INFECTION (SPECIFIC DATE AND DURATION NOT REPORTED). THE PATIENT WAS THEN PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2025 TO REMOVE THE ABUTMENT. THE INTERNAL FIXTURE REMAINS.

  Patient problems: Skin Infection

  MAUDE report 23786099 ↗
• InjuryDec 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED RECURRENT INFECTIONS AT THE ABUTMENT SITE (SPECIFIC DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Skin Infection

  MAUDE report 23786097 ↗
• InjuryNov 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED A DISCOMFORT AND SKIN INFECTION AT THE ABUTMENT SITE. THE PATIENT WAS TREATED WITH SILVER NITRATE, ORAL AND TOPICAL ANTIBIOTICS, AND UNDERWENT A SKIN REVISION SURGERY TO RESOLVE THE INFECTION. SUBSEQUENTLY, THE ABUTMENT WAS REMOVED UNDER LOCAL ANESTHESIA ON (B)(6) 2025. THERE ARE PLANS TO REPLACE THE PATIENT WITH A NEW ABUTMENT HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT.

  Patient problems: Discomfort; Skin Infection

  MAUDE report 23676989 ↗
• InjuryNov 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED A DISCOMFORT AND SKIN INFECTION AT THE ABUTMENT SITE. THE PATIENT WAS TREATED WITH SILVER NITRATE, ORAL AND TOPICAL ANTIBIOTICS, AND UNDERWENT A SKIN REVISION SURGERY TO RESOLVE THE INFECTION. SUBSEQUENTLY, THE ABUTMENT WAS REMOVED UNDER LOCAL ANESTHESIA ON (B)(6) 2025. THERE ARE PLANS TO REPLACE THE PATIENT WITH A NEW ABUTMENT HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT.

  Patient problems: Discomfort; Skin Infection

  MAUDE report 23676987 ↗
• InjuryNov 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED CELLULITIS AT THE IMPLANT SITE AND WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS AND TOPICAL STEROID OINTMENT (SPECIFIC DATE AND DURATION NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Cellulitis

  MAUDE report 23591049 ↗
• InjuryNov 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED CELLULITIS AT THE IMPLANT SITE AND WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS AND TOPICAL STEROID OINTMENT (SPECIFIC DATE AND DURATION NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Cellulitis

  MAUDE report 23591047 ↗
• InjuryNov 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED RECURRENT FLUID DRAINAGE, BLEEDING AND GRANULATION TISSUE FORMATION AT THE ABUTMENT SITE. SUBSEQUENTLY, THE ABUTMENT WAS REMOVED UNDER GENERAL ANESTHESIA ON (B)(6) 2025.

  Patient problems: Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Impaired Healing

  MAUDE report 23566726 ↗
• InjuryNov 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED RECURRENT FLUID DRAINAGE, BLEEDING AND GRANULATION TISSUE FORMATION AT THE ABUTMENT SITE. SUBSEQUENTLY, THE ABUTMENT WAS REMOVED UNDER GENERAL ANESTHESIA ON (B)(6) 2025.

  Patient problems: Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Impaired Healing

  MAUDE report 23566725 ↗
• InjuryAug 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION SUBSEQUENT TO SUSTAINING A HEAD TRAUMA. REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Head Injury; Inadequate Osseointegration

  MAUDE report 22920314 ↗
• InjuryAug 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION SUBSEQUENT TO SUSTAINING A HEAD TRAUMA. RE-IMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Head Injury; Inadequate Osseointegration

  MAUDE report 22920312 ↗
• InjuryJun 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE AND SUBSEQUENTLY WAS TREATED WITH ORAL AND IV ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). HOWEVER, THE ISSUE COULD NOT BE RESOLVED AND THE DEVICE WAS EXPLANTED UNDER GENERAL ANESTHESIA ON (B)(6) 2025. THERE ARE NO PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Skin Infection

  MAUDE report 22191815 ↗