BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04413

    MDR report key: 3232680 · Received July 18, 2013

    Report

    Report Number
    2520274-2013-04413
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 26, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR TWO UNKNOWN SCREWS. IMPLANT DATE APPROXIMATELY FIVE YEARS AGO. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODE - HSB. THE SCREWS SHOW SIGNS OF HEAVY USE WITH THE TREADS BEING MASHED, OVERALL DISCOLORATION, AND WORN HEX HEADS. ONE SCREW IS BROKEN AND THE TIP IS MISSING. THE SCREWS ARE FROM AN UNKNOWN LOT AND UNKNOWN PART NUMBER. THE MATERIAL OF THE SCREWS WAS DETERMINED TO BE TITANIUM-ALUMINUM-NIOBIUM ALLOY. BASED ON THE LACK OF INFORMATION, THE UNKNOWN ROOT CAUSE, AND THE EVALUATION PERFORMED BY SYNTHES, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. CORRECTED SPELLING FOR ONE OF THE CONDITIONS REPORTED ON INITIAL REPORT. THIS REPORT IS FOR FOUR UNKNOWN SCREWS. INITIAL REPORT STATED TWO UNKNOWN SCREWS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF COMPLETE PARAPLEGIA AT T4-T5 SINCE 1979, STATUS POST RIGHT INTRAMEDULLARY NAIL FIVE YEARS AGO, WAS RECENTLY ADMITTED FOR SURGERY. THE PATIENT HAD AN EXPOSED IM NAIL UNDER THE RIGHT TROCHANTERIC PRESSURE ULCER FOR THREE MONTHS. HE ALSO HAD ASSOCIATIVE UNSTAGEABLE ULCERS OVER THE SACRUM AND LEFT ISCHIUM. ON (B)(6) 2013, THE PATIENT WAS RETURNED TO THE OR FOR REMOVAL OF THE IM NAIL. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335635 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention