BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLT Ø4.9 SELF-TAP L30 TAV GREEN

    MDR report key: 3765048 · Received April 22, 2014

    Report

    Report Number
    3009417901-2014-10013
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Report Date
    April 7, 2014
    Manufacturer
    SYNTHES SALZBURG
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HWC. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD (S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A BLADE WAS CUT-OUT ON (B)(6) 2014. ON (B)(6) 2014 THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE FOR A FEMORAL TROCHANTERIC FRACTURE. THE PATIENT STARTED WEIGHT LOADING RIGHT AFTER THE FIXATION. ON (B)(6) 2014 A BONE COMPACTION WAS FOUND VIA X-RAY. ON (B)(6) 2014 THE BLADE WAS CUT OUT. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241875 BOLT Ø4.9 SELF-TAP L30 TAV GREEN ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES SALZBURG 5923128

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR