BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJUSTABLE CERVICAL DISTRACTOR-RIGHT

    MDR report key: 4915964 · Received July 15, 2015

    Report

    Report Number
    9680938-2015-10062
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Report Date
    May 11, 2015
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. SERVICE HISTORY REVIEW: LOT (B)(4)/5040231 - NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS JULY 15, 2005. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THE ITEM HAD HAIRLINE CRACKS. THE REPAIR TECHNICIAN REPORTED THE DISTRACTOR WAS BROKEN. DAMAGED COMPONENT IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE COMPLAINT HANDLING UNIT ON JUNE 4, 2015. MANUFACTURING INVESTIGATION EVALUATION: THE DEVICE WAS RECEIVED IN FIVE PIECES AND THE JOINT HAS SHEARED OFF. THE PIN HOLDING THE JOINT WAS NOT RECEIVED. ON EVERY HOLE ARE REMAINS OF WELD SEAM. THE MANUFACTURING EVALUATION SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE IS OVER 10 YEARS OLD. THE DESIGN WAS CHANGED THEREAFTER TO STRENGTHEN THE ARMS SO THEY DO NOT CRACK. ALL DIMENSIONS MEASURED ARE CONFORMING. THE HARDNESS WAS NOT MEASURED DUE TO THE AGE OF THE INSTRUMENT AND DUE TO THE KNOWN DESIGN ISSUES/CHANGES. DEVICE 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

    IT WAS ORIGINALLY REPORTED THAT THE ADJUSTABLE CERVICAL DISTRACTOR-RIGHT HAD HAIRLINE CRACKS AND THAT THE ADJUSTABLE CERVICAL DISTRACTOR-LEFT HAD A LEG BROKEN OFF. THESE MALFUNCTIONS WERE DISCOVERED DURING INSPECTION AND DID NOT HAVE PATIENT OR SURGICAL INVOLVEMENT. UPON COMPLETION OF THE PRODUCT INVESTIGATIONS, IT WAS DETERMINED THAT THE DISTRACTOR-RIGHT HAD ALSO BROKEN. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458774 ADJUSTABLE CERVICAL DISTRACTOR-RIGHT MISC ORTHO SURGICAL INSTR LXH SYNTHES TUTTLINGEN 5040231

    Patients

    Seq Age Sex Outcome Treatment
    1