BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHORIZONS PRA

    MDR report key: 1568981 · Received December 29, 2009

    Report

    Report Number
    1060818-2009-00004
    Event Type
    Injury
    Date Received
    December 29, 2009
    Date of Event
    December 2, 2009
    Report Date
    December 29, 2009
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEMS, INC.
    Product Code
    DZN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRA WAS PART OF THE INTERNAL SURGICAL KIT (LOT# 0802204); KITS WERE ASSEMBLED USING MULTIPLE LOT NUMBERS OF THE PRA (LOTS PO0003238, 09070113, AND 01080129), AND THE ACTUAL LOT # OF THE PRA INSTRUMENT INVOLVED COULD NOT BE DETERMINED. THE INSTRUMENT WAS NOT RETURNED FOR EVAL, AND NO ITEMS PRA OF THE LOT NUMBERS USED TO BUILD THE SURGICAL KITS REMAINED IN STOCK. FUNCTIONAL INTERFACE SHAKE TESTING WAS PERFORMED ON TWO (2) UNITS OF PRA (LOT # 0902393) FROM INVENTORY; 2/2 UNITS REMAINED SECURED IN THE TEST RATCHET, EVEN WITH VIGOROUS SHAKING, AND NO DISCREPANCIES WERE NOTED. DEVICE HISTORY RECORD REVIEW DEMONSTRATED THE DEVICE WAS MFG TO DESIGN SPECIFICATIONS.

    Description of Event or Problem · 1

    IN 2009, THE CLINICIAN REPORTED THAT WHILE PLACING AN IMPLANT INTO THE PT, THE PT ASPIRATED THE PRA (INTERNAL RATCHET & HAND WRENCH ADAPTER). PT WAS TAKEN TO A HOSP WHERE SURGERY WAS PERFORMED TO REMOVE THE INSTRUMENT FROM THE PT'S LEFT LUNG. THE NEXT DAY, BIOHORIZONS WAS INFORMED BY THE CLINICIAN'S ASSISTANT THAT NO INSTRUMENT HAD BEEN FOUND IN THE PT'S LUNGS DURING SURGERY. THE NEXT DAY, BIOHORIZONS WAS INFORMED BY THE CLINICIAN'S ASSISTANT THAT DOCTORS AT THE HOSP HAD DETERMINED THAT THE PT SWALLOWED, RATHER THAN ASPIRATED, THE INSTRUMENT; THE PT WAS EXPECTED TO PASS THE INSTRUMENT THROUGH HER DIGESTIVE TRACT WITHOUT INCIDENT, BUT THE CLINICIAN CONSIDERED THE INSTRUMENT UNRECOVERABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOHORIZONS PRA INTERNAL RATCHET & HAND WRENCH ADAPTER DZN BIOHORIZONS IMPLANT SYSTEMS, INC. PRA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R