BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REDUCTION POLY PEDICLE SCREW ÿ5.5 L50

    MDR report key: 5460552 · Received February 25, 2016

    Report

    Report Number
    3003853072-2016-00013
    Event Type
    Injury
    Date Received
    February 25, 2016
    Date of Event
    October 27, 2015
    Report Date
    January 28, 2016
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK111301
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. 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.

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED COMPLAINT AND VISUAL EVALUATION OF THE RETURNED DEVICE, NO ADDITIONAL EVALUATION WILL BE PERFORMED AS THERE IS NO REPORTED FAILURE OF THIS DEVICE OR VISUAL DAMAGE IDENTIFIED. SUPPLEMENTAL REPORT TWO OF THREE FOR THE SAME EVENT, REFERENCE 3003853072-2015-00017-3 AND 3003853072-2016-00014-1.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT WAS SCHEDULED FOR A REVISION OF FUSION FROM L4-5, L5-S1 FOR PSEUDOARTHROSIS AND EXTENSION OF FUSION TO L3-4. WHILE REMOVING THE SACRAL SCREW ON THE LEFT SIDE IT WAS NOTED TO BE BROKEN. THE PATIENT HAD AN X-RAY IN (B)(6) AND A CT SCAN IN (B)(6); THE SCREW WAS NOT IDENTIFIED TO BE BROKEN IN THE X-RAY OR THE CT SCAN. THE PATIENT STATES HE WAS ON A LONG ROAD TRIP IN (B)(6) AND HIT SEVERAL BUMPS OR DEPRESSIONS IN THE ROAD. HE REPORTS HAVING IMMEDIATE ONSET OF BACK PAIN THAT CONSEQUENTLY WORSENED INTO SEVERE PAIN, AND NUMBNESS WITH WEAKNESS IN HIS THIGHS. PATIENT'S ORIGINAL SURGERY INDICATIONS WERE AS FOLLOWS: STENOSIS AT LUMBAR 4-5, LUMBAR 5-SACRAL 1 STENOSIS WITH INSTABILITY AT L4-5 WITH NEUROGENIC CLAUDICATION. LUMBAR 4-5, LUMBAR 5-SACRAL 1 POSTERIOR DECOMPRESSION, INTERBODY FUSION AND INSTRUMENTATION. EXPLANT AND REPLACE HARDWARE WITH ADDITIONAL LEVEL, LUMBAR 3-4, DUE TO JUNCTIONAL INSTABILITY. LUMBAR 3-4, 4-5, LUMBAR 5-SCARAL 1 ALIF ON DAY TWO. PATIENT WAS DISCHARGED IN STABLE CONDITION ON DAY TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118623 REDUCTION POLY PEDICLE SCREW ÿ5.5 L50 SCREW NKB ZIMMER SPINE N/A H23491E

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R