BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R90 SPACER

    MDR report key: 2192775 · Received August 5, 2011

    Report

    Report Number
    1030489-2011-01008
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    May 11, 2012
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    NKB
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT THE PEEK SPACER IS BROKEN INTO SEVERAL PIECES. A CLEAR CONCLUSION IS UNABLE TO BE DRAWN REGARDING THE REASON FOR THE EVENT.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 2910534L, PRODUCT CODE MQP WAS CLEARED IN THE UNITED STATES. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 2910534L, 510K # K033926 WAS CLEARED IN THE UNITED STATES. (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SURGICAL PROCEDURE. DURING IMPLANTATION OF THE DEVICE, BILATERAL DILATION WAS ACHIEVED USING DISTRACTORS. THE LEFT-SIDED IMPLANT WAS ASSEMBLED ON ITS CORRESPONDING INSERTER AND INTRODUCED INTO THE DISC SPACE. ROTATION OF THE IMPLANT WAS DIFFICULT AND REQUIRED MORE FORCE THAN IS USUAL. DURING THE ROTATION, A LOUD CRACK WAS AUDIBLE. UPON INVESTIGATION IT BECAME CLEAR THAT THE IMPLANT HAD BROKEN. THE ANTERIOR 2/3RDS OF THE DEVICE WERE INTACT BUT THE POSTERIOR THIRD SHATTERED INTO APPROXIMATELY 7 PIECES. REMOVAL OF THE IMPLANT WAS DIFFICULT, REQUIRING THE SURGEON TO DISTRACT THE DISC SPACE ON THE ROD/PEDICLE SCREW CONSTRUCT. IT IS BELIEVED THAT ALL OF THE PIECES OF THE IMPLANT WERE RECOVERED FROM THE DISC SPACE. THE SURGEON IMPLANTED ANOTHER DEVICE OF THE SAME SIZE WITHOUT INCIDENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R90 SPACER NKB MSD DEGGENDORF MFG 2900537L SJ22

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR