BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTOBAND CP IMPLANT SYSTEM

    MDR report key: 8465534 · Received March 29, 2019

    Report

    Report Number
    3011421599-2018-00001
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    December 20, 2017
    Report Date
    January 15, 2018
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS LLC
    Product Code
    HRS
    UDI-DI
    00815432023639
    PMA / PMN Number
    K160300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION WERE INCONCLUSIVE BASED ON THE INFORMATION AVAILABLE AND THE EVALUATION OF THE X-RAY. PATIENT COMPLIANCE FOLLOWING IMPLANTATION OF THE DEVICE IS UNKNOWN. SEVERAL ADDITIONAL PATIENT FACTORS WERE PRESENT WHICH COULD HAVE NEGATIVELY IMPACTED THE OUTCOME OF THE SURGERY. THESE FACTORS INCLUDE THYROID DISEASE, DEPRESSION, SMOKING, AND COMPLEX SURGICAL HISTORY RESULTING FROM A MOTOR VEHICLE CRASH. THE DYNAFORCE STAPLE AND MOTOBAND MAX PLATE WERE USED IN COMBINATION WITH COMPETITOR PRODUCT (LAG SCREW ACROSS THE JOINT AND ALLOGRAFT IN THE FUSION SITE). THE MECHANICAL FACTORS ASSOCIATED WITH THE COMBINATION OF THESE ADDITIONAL DEVICES ARE UNKNOWN. THE BONE FIXATION PLATE WAS USED IN CONJUNCTION WITH PLATE SCREWS (PART NUMBER - 1500-3518, LOT-101414 & PART NUMBER - 1500-3520, LOT 101415) AS WELL AS A DYNAFORCE BONE FIXATION STAPLE IMPLANT (PART NUMBER 7118-1818KT, LOT-500009). ADDITIONALLY, THE CONSTRUCT INCLUDED A LAG SCREW AND ALLOGRAFT WHICH WAS MADE BY A DIFFERENT MANUFACTURER.

    Description of Event or Problem · 1

    PLATE AND STAPLE CONSTRUCT WAS IMPLANTED (B)(6) 2017. DURING ROUTINE FOLLOW UP VISITS, IT WAS NOTED THAT THERE WAS PAIN DURING EXAMINATION AND A LACK OF BONY UNION. THE CONSTRUCT WAS EXPLANTED DURING A REVISION SURGERY ON (B)(6) 2017 DUE TO THE NON-UNION OF THE FUSION SITE. DURING REMOVAL OF THE HARDWARE, THE DOCTOR MENTIONED THE IMPLANTS FELT LOOSE IN THE BONE. BASED ON X-RAY, THE SCREW APPEARS TO HAVE LOOSENED AND BACKED OUT OF THE HOLE, THUS CAUSING THE PLATE TO LOOSEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260069 MOTOBAND CP IMPLANT SYSTEM SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE/ BONE PLATE HRS CROSSROADS EXTREMITY SYSTEMS LLC 102018 00815432023639

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention