BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVERSE CONNECTOR, ROD TO ROD, 30MM

    MDR report key: 6949957 · Received October 13, 2017

    Report

    Report Number
    3012447612-2017-00557
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    September 17, 2017
    Report Date
    March 26, 2018
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    KWP
    PMA / PMN Number
    PK133556
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: LOT NUMBER, CONCLUSIONS - CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    THE RETURNED CONNECTOR WAS EVALUATED. THE DEVICE WAS DISASSEMBLED WITH ONE END STILL ATTACHED TO THE MATING ROD. THE THREADS ARE DAMAGED, THE DOVETAILS ARE DAMAGED, AND THERE ARE VISUAL INDICATIONS OF USE ON SEVERAL AREAS OF THE CONNECTOR. THE NUTS ARE ABLE TO DISASSEMBLE ON BOTH SIDES OF THE CONNECTOR DUE TO THE DAMAGED DOVETAILS. THE CAUSE IS MOST LIKELY ATTRIBUTED TO TIGHTENING OF ONE END OF THE CONNECTOR ON A ROD AND THEN ATTEMPTING TO CONNECT THE OPPOSITE END OF THE CONNECTOR ON THE SECOND ROD. THE DEVICE LABELING INSTRUCTS THE USER TO SEAT BOTH ENDS OF THE CONNECTOR ONTO THE RODS BEFORE TIGHTENING EITHER END. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH MAY HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ROD TO ROD CONNECTOR WOULD NOT ATTACH TO A ROD DURING INSTALLATION WITHIN SURGERY. ONE SIDE OF THE CONNECTOR ATTACHED TO A ROD BUT THE OPPOSITE END WOULD NOT CONNECT TO THE SECOND ROD. THE CONNECTOR THEN COULD NOT BE DISCONNECTED FROM THE FIRST ROD SO THE SURGEON REMOVED THE FIRST ROD AND THE CONNECTOR, THEN INSTALLED AN ALTERNATIVE ROD TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT IMPACTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727256 TRANSVERSE CONNECTOR, ROD TO ROD, 30MM VIRAGE OCT SPINAL FIXATION SYSTEM KWP ZIMMER BIOMET SPINE INC. NA 63188461

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR