BEUDAMED
    FDA Adverse Event Other Summary report: N

    LINK MP TRIAL NECK SEGMENT

    MDR report key: 2492471 · Received March 8, 2012

    Report

    Report Number
    9610548-2012-00008
    Event Type
    Other
    Date Received
    March 8, 2012
    Date of Event
    December 19, 2011
    Report Date
    March 8, 2012
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    JDI
    PMA / PMN Number
    K955296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE STARTED A VOLUNTARY PRODUCT RECALL IN THE COUNTRIES WHICH WE DELIVERED WITH THE AFFECTED PRODUCTS ((B)(4)). THE INFO OF THE RECALL IS ENCLOSED. THIS EVENT OCCURRED OUTSIDE OF THE U.S AND INVOLVED A PRODUCT THAT WAS MFG OUTSIDE OF THE U.S. HOWEVER, BECAUSE THE LINK MP RECONSTRUCTION SYSTEM ALSO IS MARKETED IN THE U.S LINK IS SUBMITTING THIS MDR TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

    Description of Event or Problem · 1

    THE CUSTOMER OPENED A 131-394/35 TRIAL NECK SEGMENT MARKED AS CCD 135 DEGREES, BUT IN FACT THE ONE IN THE BOX IS A CCD 126 DEGREES. (B)(4) 2011: OUR DISTRIBUTOR (B)(4), INFORMED US THAT A CUSTOMER OPENED A 131-394/35 TRIAL NECK SEGMENT MARKED AS CCD 135 DEGREES, BUT IN FACT THE ONE IN THE BOX IS A CCD 126 DEGREES. AT THIS TIME NO FURTHER INVESTIGATION POSSIBLE BECAUSE WE DIDN'T RECEIVE THE LOT NUMBER FROM THE USER. FEB 6TH, 2012: COMPLAINT SAMPLE RECEIVED AND JUSTIFIED. ACCORDING TO OUR DOCUMENTATION TWO BATCHES WERE MIXED UP DURING THE PRODUCTION PROCESS AND FINALLY INCORRECTLY LABELED. REF 131-394/35 LOT: A911205 10 PIECES: LABELLED CCD ANGLE 135 DEGREES, PHYSICAL CCD ANGLE 126 DEGREES. REF: 131-394/26 LOT: A911179 10 PIECES: LABELLED CCD ANGLE 126 DEGREES, PHYSICAL CCD ANGLE 135 DEGREES. DUE TO THE FACT THAT NO ITEM OF THE COMPLEMENT BATCH ((B)(4)) WAS ON STOCK WE NEEDED TO CHECK IT AT CUSTOMER SITE, WHICH WAS CONFIRMED ON 24TH FEB, 2012 BY OUR DISTRIBUTOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINK MP TRIAL NECK SEGMENT MP TRIAL NECK SEGMENT JDI WALDEMAR LINK GMBH & CO. KG 131-394/35 A911205

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention