BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL LOCK NUT, 8MM

    MDR report key: 4781748 · Received May 19, 2015

    Report

    Report Number
    1526439-2015-10472
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 20, 2015
    Report Date
    April 20, 2015
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK101070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE REPORTED INSTRUMENTS COULD NOT MATE WITH THE EXPEDIUM CONICAL NUTS [PRODUCT CODE: 1754-91-150, LOT NUMBER: ARNDC7]. THIS WAS CONFIRMED THROUGH THE INVESTIGATION CONDUCTED BY THE ESCALATION TEAM. AS A RESULT, A HEALTH HAZARD EVALUATION (HHE) 103134971 REV 1, WAS CONDUCTED TO ADDRESS THE ASSOCIATED PATIENT RISK. BASED ON THE HHE HARMS SCORE, THIS ISSUE WAS ESCALATED TO THE QUALITY REVIEW BOARD. THE DECISION WAS MADE TO RECALL AFFECTED LOTS ARNDC7 AND ARNDC6. BASED ON THE 12 MONTH TRENDING, ALL RELATED COMPLAINTS ARE ASSOCIATED WITH THE EFFECTED RECALL LOTS. (B)(4) WAS OPENED TO INVESTIGATE ROOT CAUSE AND IDENTIFY ANY NECESSARY CORRECTIVE ACTIONS. AS SUCH NO FURTHER COMPLAINT INVESTIGATION ACTIONS ARE DEEMED NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MFR IS INCORRECT AND SHOULD BE APR 20, 2015. 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

    THE CONICAL NUT DIDN'T FIT THE APPROPRIATE INSTRUMENTS. THE SURGEON REPORTED AN IDENTICAL INCIDENT (B)(4) WITH ANOTHER LOT NUMBER, ONE MONTH AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325829 CONICAL LOCK NUT, 8MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE ARNDC6

    Patients

    Seq Age Sex Outcome Treatment
    1