BCI Bone Conduction Implant Kit 51032Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 09008738510328), received between Nov 14, 2019 and Oct 17, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2023No Device Output; No Device Output

  THE USER REPORTED THAT IN (B)(6) 2023 HE LOST ACCESS TO SOUND WITH THE DEVICE.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949074 ↗
• InjuryJun 8, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER REPORTED PAIN AT THE IMPLANT SITE. THE DEVICE WAS STILL FUNCTIONING PRIOR TO BEING REMOVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2020. ACCORDING TO THE EXPLANTATION REPORT THERE WAS AN EXTRUSION AND WOUND HEALING ISSUES. IN ADDITION THERE WAS A REPORT OF BIOFILM FORMATION.

  Patient problems: Tissue Breakdown; Unspecified Infection

  MAUDE report 10127142 ↗
• InjuryJun 4, 2020Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  THE CLINIC REQUESTED AN EXPLANT KIT BECAUSE THE DEVICE WAS REMOVED. AT THE TIME THE COMPLAINT WAS MADE THE NURSE WHO REQUESTED THE KIT DID NOT HAVE ANY FURTHER INFORMATION ON THE REASON FOR REMOVAL. ADDITIONAL INFORMATION RECEIVED STATED THAT THE USER REPORTED PAIN AT THE IMPLANT SITE AND THAT WAS THE REASON FOR THE EXPLANTATION. IT WAS CONFIRMED THAT THE SURGICAL WOUND DID HEAL COMPLETELY AFTER IMPLANTATION. THERE WAS NO INFECTION PRESENT AND THE SKIN ABOVE THE IMPLANT WAS INTACT.

  Patient problems: Pain; Tissue Breakdown

  MAUDE report 10118554 ↗
• MalfunctionNov 14, 2019Output Problem; Output Problem

  THE DEVICE WAS SUCCESSFULLY ACTIVATED EARLIER IN 2019. IN (B)(6) 2019, AFTER LOSING THE EXTERNAL DEVICE, THE RECIPIENT WAS PLAYING ON THE PLAYGROUND AND HIT HIS HEAD. IN (B)(6) 2019 THE AUDIO PROCESSOR WAS FOUND AND AFTER PUTTING IT ON THE DEVICE ONLY WORKED FOR ONE DAY. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9320644 ↗