BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI LENGTHENING APPARATUS 160MM

    MDR report key: 3070666 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-10943
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    September 19, 2011
    Report Date
    October 11, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    MQN
    PMA / PMN Number
    K973018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ORIGINAL AWARENESS DATE IS (B)(4) 2011.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE INSIDE THREADS ARE FROZEN TOGETHER. WE ARE NOT ABLE TO DETERMINE THE REASON THEREFORE. THE DEVICE DOES NOT HAVE THE LOOK TO BE FORCIBLE USED. THE MANUFACTURING RECORDS SHOW THAT ALL SIX ARTICLES OF THE CONCERNED LOT MET TO OUR SPECIFICATIONS AT THE TIME OF DISTRIBUTING. THE COMPLAINT HAS BEEN DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE CONSULTANT THAT THE MINI LENGTHENING APPARATUS WOULD NOT DISTRACT OR COMPRESS DURING A PROCEDURE. A SECOND APPARATUS WAS BORROWED FROM A SISTER FACILITY TO COMPLETE THE PROCEDURE. HOSPITAL IS UNABLE TO DISASSEMBLE THE DEVICE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171519 MINI LENGTHENING APPARATUS 160MM MQN SYNTHES GMBH 2561683

    Patients

    Seq Age Sex Outcome Treatment
    1