Conform™ Extended Anatomical Chin Size: MediumRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M724CEACM1), received between Apr 19, 2018 and May 26, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2021Appropriate Device Problem Term/Code Not Available

  COMPLAINANT REPORTED THAT PATIENT INITIALLY PRESENTED WITH ISSUES MORE THAN 3 WEEKS POST-OPERATIVELY AFTER CHIN IMPLANT WAS PLACED INTRAORALLY, AND SUBSEQUENTLY WAS DIAGNOSED WITH AN INFECTION. PATIENT WAS STARTED ON CIPRO (P.O.) AND DOXYCYCLINE (P.O.) AND A CULTURE WAS TAKEN. THE CULTURE IDENTIFIED STAPHYLOCOCCUS AUREUS, AND PATIENT WAS SWITCHED TO CLYNDOMYCIN (P.O.) WHEN SYMPTOMS DID NOT RESOLVE QUICKLY, THE PATIENT HAD THE SITE DRAINED AND RECEIVED NEW COURSES OF CLYNDOMYCIN. INFECTION DID NOT RESOLVE, AND PATIENT HAD THE DEVICE EXPLANTED APPROXIMATELY 10.5 WEEKS POST-OPERATIVELY.

  Patient problems: Bacterial Infection; Fluid Discharge

  MAUDE report 11886916 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem

  COMPLAINANT REPORTED THAT PATIENT PRESENTED WITH ISSUES 8 DAYS AFTER CHIN IMPLANT WAS PLACED INTRAORALLY, AND WAS SUBSEQUENTLY DIAGNOSED WITH AN INFECTION. PATIENT WAS TREATED WITH CIPRO (P.O.) AND DOXYCLYCLIN (P.O.), HOWEVER WHEN RESULTS OF A CULTURE IDENTIFIED STREPTOCOCCUS VIRIDANS, THE AREA WAS DRAINED AND PATIENT WAS SWITCHED TO CLYNDOMYCIN (P.O.) THE PATIENT'S SYMPTOMS DID NOT IMPROVE, AND THE PATIENT HAD THE SITE DRAINED AND NEW COURSES OF CLYNDOMYCIN (P.O.) PRESCRIBED. THE INFECTION IS NOW CONSIDERED TO BE RESOLVED.

  Patient problems: Bacterial Infection; Fluid Discharge

  MAUDE report 11886733 ↗
• InjuryApr 19, 2018Break; Break

  COMPLAINANT REPORTED THAT PATIENT COMPLAINED OF NUMBNESS AND SWELLING APPROXIMATELY 4 WEEKS POST SURGERY AFTER HAVING CHIN IMPLANT IMPLANTED. THE PHYSICIAN FOUND THE END OF THE ARM OF THE CHIN IMPLANT WAS KINKED OR BENT AT 90 DEGREE ANGLE ON THE PATIENT'S RIGHT SIDE. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE DEVICE. EXPLANT/REPLACEMENT SURGERY OCCURRED APPROXIMATELY 7 WEEKS POST-OPERATIVELY. THE PHYSICIAN INDICATED THAT THE END OF THE DEVICE HAD BROKEN OFF. AFTER REPLACEMENT SURGERY, PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: Numbness; Swelling

  MAUDE report 7443485 ↗