BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH

    MDR report key: 3485555 · Received November 25, 2013

    Report

    Report Number
    2520274-2013-07386
    Event Type
    Malfunction
    Date Received
    November 25, 2013
    Date of Event
    October 30, 2013
    Report Date
    October 30, 2013
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURE LOT NUMBER 6993691, LOT NUMBER FROM GERMANY 8025731 (STERILIZATION). THE DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE PART WAS STERILIZED AT (B)(4) BUT MANUFACTURED THE USA: REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    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.DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. REVIEW OF THE DHR SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE PRODUCT DEVELOPMENT EVALUATION CONCLUDED THAT IT IS NOT POSSIBLE TO DETERMINE IF THE HOLDING SLEEVE WAS CORRECTLY ENGAGED IN THE BONE SCREW BY THE USER AND / OR IF EXCESSIVE FORCES WERE APPLIED DURING INSERTION. DEVICE WAS NOT IMPLANTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE HEAD OF THE SCREW SUDDENLY CAME OFF AS THE SURGEON WAS IMPLANTING IT IN THE PATIENT. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612977 7.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH NKB SYNTHES (USA) BRANDYWINE 8025731

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR