BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04616

    MDR report key: 3310786 · Received August 27, 2013

    Report

    Report Number
    2520274-2013-04616
    Event Type
    Injury
    Date Received
    August 27, 2013
    Report Date
    July 31, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    OFB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW BY POST MARKET RISK, GIVEN THE ACUTE TIME FRAME OF THIS DEATH, THE EVENT IS DEEMED TO BE SERIOUS INJURY WITH AN OUTCOME OF DEATH. USE OF THE DEVICE CANNOT BE ELIMINATED AS ASSOCIATED WITH THE DEFINED EVENT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF REPORT: 2001 ; 104 (2) :182-186. ADD'L DEVICE INFO: CANNOT BE DETERMINED WITHOUT A PART NUMBER. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: NO SUSPECTED ASSOCIATION BETWEEN DEATH AND THE USE OF THE PRODUCT. CORRECTION TO OUTCOMES ATTRIBUTED TO ADVERSE EVENT FROM DEATH TO OTHER SERIOUS. TYPE OF REPORTABLE EVENT WAS CORRECTED FROM DEATH TO SERIOUS INJURY.

    Description of Event or Problem · 1

    AN ABSTRACT WAS RECEIVED: FATAL INJURY TO THE EXTERNAL ILIAC VEIN BY A GUIDE WIRE DURING USE OF A DYNAMIC HIP SCREW (DHS); UNFALLCHIRURG. 2001 ; 104 (2) :182-186. AUTHORS: SIEGEL A., SCHULZ F., PUSCHEL K. IT WAS REPORTED VIA THE ABSTRACT THAT THE GUIDE WIRE OF A DYNAMIC HIP SCREW CAUSED A FATAL INJURY TO THE EXTERNAL ILIAC VEIN IN AN UNIDENTIFIED PATIENT. THIS INJURY WAS NOT AT FIRST EVIDENT. THE GUIDE WIRE BECAME CAUGHT UP IN THE COMBINATION THREE-DIAMETER DRILL AND SCREWED BY THE DRILL INTO THE PELVIS. THE PATIENT SUFFERED A CIRCULATORY COLLAPSE AFTER STABLE INTERVAL. EMERGENCY TREATMENT AND RESUSCITATION WERE ATTEMPTS FOLLOWED WITH NO POSSIBILITY OF SURGICAL INTERVENTION. IN A POSTMORTEM EXAMINATION, THE NATURE OF THE PATIENTS INJURY WAS ESTABLISHED AND DESCRIBED. REPORTEDLY THE DISTANCES WERE MEASURED ON THE ACTUAL BONE. TWO EXPERTS EVALUATING THIS INCIDENT CONCLUDED THAT THIS INCIDENT WAS A RARE INJURY THAT WAS NOT DUE TO MALPRACTICE. THIS REPORT IS FOR A TRAUMA DEVICE (PART/LOT NUMBER WAS NOT SPECIFIED). IT IS UNKNOWN IF IT WAS A SYNTHES DEVICE. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419526 OFB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O