BIODESIGN G44451Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002444515), received between Oct 14, 2019 and Sep 28, 2020 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IN (B)(6) 2019, DR. (B)(6) PLACED A BIODESIGN OTOLOGIC REPAIR GRAFT FOR A TYMPANOPLASTY. THE PATIENT REPORTEDLY DEVELOPED IMMEDIATE EAR DRUM SWELLING AND PAIN POST OPERATIVELY. DR. (B)(6) STATED IT LOOKED LIKE A REJECTION WITH FOREIGN BODY REACTION. THE PATIENT'S EAR DRUM WAS RED AND INFLAMED AND CONTINUED TO SWELL WITH BULGING INTO THE EAR CANAL. THE PATIENT FAILED MULTIPLE (UNSPECIFIED) TREATMENTS. A POSTOPERATIVE CT SCAN SHOWED A SOFT TISSUE MASS IN THE EAR DRUM EXTENDING INTO THE MIDDLE EAR AND INTO THE EUSTACHIAN TUBE. DR. SAJJADI PERFORMED AN ENDOSCOPIC REVISION TYMPANOPLASTY. DR. (B)(6) STATED THE GRAFT MATERIAL HAD CAUSED MASSIVE FIBROTIC REACTION WHICH WRAPPED AROUND THE OSSICLES AND EXTENDED FROM THE EAR DRUM INTO THE MIDDLE EAR AND EUSTACHIAN TUBE; A MASSIVE REACTIVE RESPONSE AND THE MASS WENT EXACTLY WHERE THE GRAFT WAS INSERTED. CBI'S CHIEF SCIENTIFIC OFFICER HAD A PHONE CONVERSATION WITH DR. (B)(6). THE FOLLOWING DETAILS WERE OBTAINED FROM THAT COMMUNICATION. DR. (B)(6) HAD TO GO REOPERATE TO REMOVE THE GRAFT AND DO COMPLICATED SURGERY TO SAVE THE EAR FLAP AND THE OSSICLES FROM A SIGNIFICANT OVERGROWTH. DR. (B)(6) REPORTED SAID IT WAS NEAR 1 CM THICK AND THE MARGINS F

  Patient problems: Local Reaction

  MAUDE report 10597031 ↗
• InjuryOct 14, 2019Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ON (B)(6) 2019, DR. (B)(6) IMPLANTED A BIODESIGN OTOLOGIC REPAIR GRAFT FOR A RIGHT TYMPANOPLASTY. AT AN UNSPECIFIED TIME POST OP, THE PATIENT WAS BELIEVED TO HAVE HAD A REACTION TO THE GRAFT IN WHICH A MASS WAS PRESENT. THE MASS WAS IN THE EXTERNAL AUDITORY CANAL (EAC) TO THE MIDDLE EAR. THE PATIENT UNDERWENT AN EXPLORATORY TYMPANOPLASTY FOR REMOVAL OF THE MASS. THE MASS WAS SENT TO PATHOLOGY. THE GRAFT WAS NOT REMOVED IN FULL AS DOING SO WOULD HAVE RESULTED IN A PARTIAL EAR CANAL AND EAR DRUM RESECTION. THE PATIENT WAS TREATED WITH CIPRODEX (ANTIBIOTIC) PACKING. THE PATHOLOGY WAS REPORTEDLY CONSISTENT WITH A POSSIBLE REACTION TO THE GRAFT. HOWEVER, PATHOLOGY RESULTS WERE NOT AVAILABLE TO THE GRAFT MANUFACTURER.

  Patient problems: Local Reaction

  MAUDE report 9188094 ↗