BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODISC-L INSERTER F/SIZE L

    MDR report key: 3121915 · Received May 21, 2013

    Report

    Report Number
    8030965-2013-02247
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    December 13, 2010
    Report Date
    December 19, 2010
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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. DEVICE WAS USED FOR TREATMENT AND NOT DIAGNOSIS. DURING IMPLANTATION THE PIN OF THE HOLDING PIECE OF THE DEVICE USED FOR ALIGNMENT WAS BROKEN OFF. THE PARTS WERE RETRIEVED AND THE CAUSE OF THE BREAKAGE WAS DUE TO HANDLING NOT CONSISTENT WITH THE INSTRUCTIONS FOR USE.

    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. DATE OF THIS REPORT: CORRECTED DATE FROM (B)(6) 2013 TO (B)(6) 2010.

    Description of Event or Problem · 1

    DOCTOR USED THE SLOTTED HAMMER TO IMPACT THE IMPLANT INTO THE PREPARED DISC SPACE, THE PIN AT THE TOP OF THE IMPLANT HOLDER CAME OUT WHICH CAUSED THE SUPERIOR ARM OF THE HOLDER AND THE PIN TO BECOME SEPARATED FROM THE REST OF THE DEVICE. DOCTOR MANAGED TO RETRIEVE THE PIN. THIS MDR REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224137 PRODISC-L INSERTER F/SIZE L LXH SYNTHES GMBH A70A40

    Patients

    Seq Age Sex Outcome Treatment
    1