BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 976662 · Received August 20, 2004

    Report

    Report Number
    2184052-2004-00013
    Event Type
    Other
    Date Received
    August 20, 2004
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    MCV
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSP PROVIDED MEDWATCH UF/DIST. REPORT PERTAINING TO THE SAME EVENT, ALONG WITH SOME OF THE RETURNED EXPLANTED DEVICES. THIS REPORT ADDRESSES THE REPORT SUBMITTED BY THE HOSP. IF ADD'L INFO IS OBTAINED TO FACILITATE FURTHER INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PARTS RETURNED INCLUDE A 6.5X40MM POLYAXIAL PEDICLE SCREW (PART# 7220-6540-00, LOT P010542), A 6.5X35MM POLYAXIAL PEDICLE SCREW ((PART#7720-6535-00, LOT P000661) AND TWO LOCKING NUTS (PART# 7220-1020-00, LOT#S P000828 AND P010006). THE 6.5X40MM POLYAXIAL PEDICLE SCREW AND THE LOCKING NUT (LOT#P010006) WERE VISUALLY EXAMINED. THERE WERE NO MARKINGS CONSISTENT WITH ABNORMAL WEAR OF THE ROD ON THE SCREW HEAD OR LOCKING NUT. IT IS UNCLEAR WHETHER THE MATERIALS MGMT DEPT AT THE HOSP CONDUCTED PHYSICAL OR MECHANICAL TESTING OF THESE SCREWS. POSTOPERATIVE SECTION STATES, "IMPLANT REMOVAL MUST BE CONSIDERED AFTER FUSION HAS OCCURRED DUE TO THE POSSIBILITY OF IMPLANT LOOSENING, FRACTURE OR CORROSION." VISUAL EXAMINATION OF BROKEN SCREWS WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * MCV ZIMMER SPINE, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1