BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUICK-FIT MOLAR BAND ASSEMBLIES

    MDR report key: 2593894 · Received May 24, 2012

    Report

    Report Number
    1056191-2012-00001
    Event Type
    Other
    Date Received
    May 24, 2012
    Date of Event
    April 26, 2012
    Report Date
    May 24, 2012
    Manufacturer
    ORTHO TECHNOLOGY, INC
    Product Code
    ECM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE THE LEGAL MANUFACTURER OF THE QUICK-FIT BAND ASSEMBLIES AND OBTAIN THEM FROM A MANUFACTURER IN (B)(4). THE BANDS THAT FAILED WERE NOT RETURNED FOR EVALUATION, HOWEVER THE CUSTOMER SENT BACK THE REMAINING BANDS FROM THEIR STOCK AND WE TESTED THEM AT OUR FACILITY. WE ALSO SENT A SAMPLING OF THE RETURNED BANDS TO THE MANUFACTURER FOR TESTING AS WELL. THE MANUFACTURER CONCLUDED THERE IS AN ISSUE IN THEIR MANUFACTURING PROCESS AND QC PROCESSES THAT DID NOT DETECT THE ISSUE IN OUR CUSTOMER'S RETURNED PRODUCT. ALL OF OUR INVENTORY WAS QUARANTINED AS SOON AS THIS INFORMATION WAS DETERMINED AND IT HAS ALL BEEN SENT BACK TO THE MANUFACTURER'S COUNTERPART IN THE US FOR EVALUATION, REPAIR OR REPLACEMENT. AT THIS TIME THEY ARE ENSURING THEIR PROPOSED CORRECTIVE ACTION IS EFFECTIVE BEFORE RETURNING ANY PRODUCT TO US. IN THE MEANTIME, WE ARE BACKORDERING QUICK-FIT ORDERS AND/OR SUGGESTING A SUBSTITUTE.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE REPORTED THEY HAVE HAD AN ISSUE WITH WELDS FAILING IN ORTHODONTIC STAINLESS STEEL BANDS AND THIS ULTIMATELY CAUSED AN ISSUE REQUIRING MEDICAL INTERVENTION IN 2 PATIENTS. THE FIRST PATIENT, A (B)(6) FEMALE, WAS WEARING A FORCES APPLIANCE, THAT WAS PLACED IN THE MOUTH UTILIZING OUR ORTHODONTIC QUICK-FIT MOLAR BAND ASSEMBLIES. THE BUCCAL TUBE BROKE AWAY FROM THE BAND. THIS OCCURRED IN THE MIDDLE OF THE NIGHT AND BY THE TIME THE PATIENT REACHED THE ORTHODONTIST'S OFFICE THE BUCCAL MUCOSA WAS CUT AND COMPLETELY IRRITATED. SHE HAD SWELLING ON HER CHEEK. THE DOCTOR ADMINISTERED A MIXTURE OF BENZOCAINE AND ANTIBIOTICS TO FACILITATE HEALING AND PRESCRIBED ORAL ANTIBIOTICS AS WELL. A SECOND PATIENT, A (B)(6) MALE UTILIZING THE SAME TYPE OF FORCES APPLIANCE HAD A VERY SIMILAR PROBLEM AND THE DOCTOR TREATED THE EXACT SAME.

    Additional Manufacturer Narrative · 2

    WE ARE THE LEGAL MANUFACTURER OF THE QUICK-FIT BAND ASSEMBLIES AND OBTAIN THEM FROM A MANUFACTURER IN BRAZIL. THE BANDS THAT FAILED WERE NOT RETURNED FOR EVALUATION, HOWEVER, THE CUSTOMER SENT BACK THE REMAINING BANDS FROM THEIR STOCK AND WE TESTED THEM AT OUR FACILITY. WE ALSO SENT A SAMPLING OF THE RETURNED BANDS TO THE MANUFACTURER FOR TESTING AS WELL. THE MANUFACTURER CONCLUDED THERE IS AN ISSUE IN THEIR MANUFACTURING PROCESS AND QC PROCESSES THAT DID NOT DETECT THE ISSUE IN OUR CUSTOMER'S RETURNED PRODUCT. ALL OF OUR INVENTORY WAS QUARANTINED AS SOON AS THIS INFORMATION WAS DETERMINED AND IT HAS ALL BEEN SENT BACK TO THE MANUFACTURER'S COUNTERPART IN THE US FOR EVALUATION, REPAIR OR REPLACEMENT. AT THIS TIME THEY ARE ENSURING THEIR PROPOSED CORRECTIVE ACTION IS EFFECTIVE BEFORE RETURNING ANY PRODUCT TO US. IN THE MEANTIME, WE ARE BACKORDERING QUICK-FIT ORDERS AND/OR SUGGESTING A SUBSTITUTE.

    Description of Event or Problem · 2

    A DOCTOR'S OFFICE REPORTED THEY HAVE HAD AN ISSUE WITH WELDS FAILING IN ORTHODONTIC STAINLESS STEEL BANDS AND THIS ULTIMATELY CAUSED AN ISSUE REQUIRING MEDICAL INTERVENTION IN 2 PATIENTS. THE FIRST PATIENT, A (B)(6) FEMALE, WAS WEARING A FORCES APPLIANCE, THAT WAS PLACED IN THE MOUTH UTILIZING OUR ORTHODONTIC QUICK-FIT MOLAR BAND ASSEMBLIES. THE BUCCAL TUBE BROKE AWAY FROM THE BAND. THIS OCCURRED IN THE MIDDLE OF THE NIGHT AND BY THE TIME THE PATIENT REACHED THE ORTHODONTIST'S OFFICE THE BUCCAL MUCOSA WAS CUT AND COMPLETELY IRRITATED. SHE HAD SWELLING ON HER CHEEK. THE DOCTOR ADMINISTERED A MIXTURE OF BENZOCAINE AND ANTIBIOTICS TO FACILITATE HEALING AND PRESCRIBED ORAL ANTIBIOTICS AS WELL. A SECOND PATIENT, A (B)(6) MALE UTILIZING THE SAME TYPE OF FORCES APPLIANCE HAD A VERY SIMILAR PROBLEM AND THE DOCTOR TREATED THE EXACT SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK-FIT MOLAR BAND ASSEMBLIES ECM - ORTHODONTIC BAND/TUBE ECM ORTHO TECHNOLOGY, INC QUICK-FIT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention ORTHODONTIC ARCHWIRE| FORCES APPLIANCE| ORTHODONTIC BRACKETS
    2 15 YR FORCES APPLIANCE| ORTHODONTIC ARCHWIRE| ORTHODONTIC BRACKETS