BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIUM TI LAMINA HOOK-LEFT

    MDR report key: 3031827 · Received April 2, 2013

    Report

    Report Number
    2530088-2013-10355
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    May 22, 2012
    Report Date
    May 22, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNH
    PMA / PMN Number
    K992739
    Removal / Correction Number
    Z-2054-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. THIS REPORT IS FOR 2 MEDIUM TI LAMINA HOOK-LEFT FROM THE SAME LOT AND SAME PART NUMBER. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDE: MNI. MANUFACTURING EVALUATION REPORTS THAT THE SAMPLE WAS RECEIVED AND THE HOOK ORIENTATION DOES NOT MATCH PRODUCT DRAWING. THEREFORE THIS COMPLAINT IS DEEMED VALID FROM A MANUFACTURING PERSPECTIVE. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION PROCEDURE ON T2-L1, THE WHILE THE SURGEON INSERTED THE MEDIUM TI LAMINA HOOK-LEFT, THE SURGEON NOTICED THE HOOK WAS A RIGHT HOOK AND NOT A LEFT HOOK AS LABELED. THE REST OF THE INSTRUMENT SET WAS CHECK AND ANOTHER HOOK LABELED LEFT BUT WAS ACTUALLY A RIGHT HOOK WAS FOUND. THE SURGEON COMPLETED THE PROCEDURE USING ANOTHER TI LAMINA HOOK-LEFT WITH NO FURTHER PROBLEMS. THE PATIENT WAS UNHARMED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR FILE 9264.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134648 MEDIUM TI LAMINA HOOK-LEFT MNH SYNTHES BRANDYWINE 6876785

    Patients

    Seq Age Sex Outcome Treatment
    1