BEUDAMED
    FDA Adverse Event Other Summary report: N

    HTO PLATE SCREW 6.5 X 4.5MM CANCELLOUS TITANIUM

    MDR report key: 1182384 · Received September 30, 2008

    Report

    Report Number
    1220246-2008-00194
    Event Type
    Other
    Date Received
    September 30, 2008
    Date of Event
    July 31, 2008
    Report Date
    September 4, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    PMA / PMN Number
    K032187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. THE EXPLANTED HALF OF THE BROKEN PLATE SCREW (THE DISTAL END) WAS RECEIVED. ALL INSPECTIONS PASSED CRITERIA. THE LOT NUMBER WAS NOT PROVIDED FROM THE INITIAL REPORTER AND COULD NOT BE DETERMINED FROM THE PART RETURNED. DEVICE HISTORY RECORD REVIEW COULD NOT CONDUCTED WITHOUT THE LOT NUMBER. A DEFINITE CAUSE FOR THE EVENT COULD NOT BE DETERMINED. INFORMATION REGARDING PATIENT FACTORS SUCH AS AGE, WEIGHT, QUALITY OF BONE, ACTIVITY LEVEL AND OTHER FACTORS THAT CAN EFFECT HEALING TIME (SUCH AS SMOKING, DRINKING, POOR CIRCULATION, ETC.) COULD NOT BE OBTAINED. IT WAS REPORTED, HOWEVER, THAT THE PATIENT HAD A HISTORY OF EXTENDED FRACTURE HEALING TIME IN THE PAST. BASED ON THE INFORMATION PROVIDED AND DEVICE EVALUATION, THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS MICROMOTION OF THE SCREW WHICH CAN OCCUR IF THE PATIENT HAS POOR BONE QUALITY SURROUNDING THE IMPLANT OR IF THE PATIENT IS NON-COMPLIANT WITH THE POST -OPERATIVE PROTOCOL AND BEGINS WEIGHT BEARING TOO EARLY. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW WAS BROKEN IN HALF APPROXIMATELY SIX WEEKS POST OP; PART OF THE SCREW REMAINS INSIDE THE PATIENT. THE PATIENT WAS REPORTED TO HAVE BONE RESORPTION APPROXIMATELY SIX WEEKS AFTER THE ORIGINAL SURGERY. THE REPORT STATED "THERE WAS FORCE ONLY ON THE PLATE". NO PATIENT INJURY WAS REPORTED. THE SURGEON REPORTED THAT PATIENT'S CURRENT CONDITION AS "O.K". NO FURTHER PT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP REQUESTS TO THE REPORTER. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HTO PLATE SCREW 6.5 X 4.5MM CANCELLOUS TITANIUM HRS ARTHREX, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other INFORMATION REQUESTED BUT NOT PROVIDED