BEUDAMED
    FDA Adverse Event Other Summary report: N

    VSP SPINAL SYSTEM

    MDR report key: 384023 · Received March 20, 2002

    Report

    Report Number
    1526439-2002-00015
    Event Type
    Other
    Date Received
    March 20, 2002
    Report Date
    March 20, 2002
    Manufacturer
    DEPUY ACROMED, INC.
    Product Code
    MCV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO DEPUY ACROMED THAT A VSP SCREWS BROKE POST-OPERATIVELY. THE SCREW HAS NOT BEEN EXPLANTED. THIS WAS MENTIONED TO A DEPUY ACROMED SALES REPRESENTATIVE IN A CONVERSATION WITH THE SURGEON. NO FURTHER INFORMATION WAS REPORTED. THE INVESTIGATION OF THE PRODUCT COMPLAINT WAS NOT POSSIBLE. A RECORD REVIEW COULD NOT BE PERFORMED SINCE THE LOT INFORMATION WAS NOT PROVIDED. A DEFINITIVE CAUSE OF THE EVENT CANNOT BE DETERMINED. THE LABELING CONTAINED WITH THE PRODUCT WARNS THAT "SPINAL IMPLANTS, LIKE ANY OTHER TEMPORARY INTERNAL FIXATION DEVICES, HAVE A FINITE USEFUL LIFE...BECAUSE OF THE LIMITATIONS IMPOSED BY ANATOMIC CONSIDERATIONS AND MODERN SURGICAL MATERIAL, METALLIC IMPLANTS CANNOT BE MADE TO LAST INDEFINITELY." NO FURTHER ACTION CAN BE TAKEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VSP SPINAL SYSTEM PEDICLE SCREW MCV DEPUY ACROMED, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other