BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR CUSTOMIZED-MANDIBLE

    MDR report key: 11994755 · Received June 14, 2021

    Report

    Report Number
    0008010177-2021-00036
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    May 20, 2021
    Report Date
    August 30, 2021
    Manufacturer
    STRYKER ORTHOBIOLOGICS-MALVERN
    Product Code
    FWP
    UDI-DI
    07613252457671
    PMA / PMN Number
    K121315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT THAT ¿THE OR STAFF OPENED THE IMPLANT FOR THE SURGERY, IT WAS REALIZED THE IMPLANT HAD EXPIRED¿ COULD BE CONFIRMED. THE PRODUCT WAS DESIGNED, THEN APPROVED BY THE SURGEON AND AFTERWARDS MANUFACTURED IN TIME. AT THE TIME OF PROCEDURE, THE PRODUCT HAD ALREADY EXPIRED 16 DAYS BEFORE. THE OR STAFF RECOGNIZED THIS DURING THE PREPARATION FOR THE SURGERY AND DECIDED IN THE END TO USE THE PRODUCT AND IMPLANT IT. THIS IS IN CONTRADICTION TO THE CORRESPONDING IFU OF THE PRODUCT (S. LABELLING REVIEW). BASED ON THE PERFORMED INVESTIGATION AND THE DHR REVIEW THERE IS NO INDICATION FOR AN INCORRECTLY WORKING PRODUCT OR ANY SYSTEMATIC DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE. H3 OTHER TEXT: DEVICE IS IMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT DURING THE PROCEDURE SURGEON WAS MADE AWARE THE IMPLANT WAS EXPIRED. THE SURGEON CONTINUED WITH IMPLANTING THE IMPLANT ALTHOUGH IT IS OFF LABEL USE. THERE IS NO FURTHER INFORMATION KNOWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT DURING THE PROCEDURE SURGEON WAS MADE AWARE THE IMPLANT WAS EXPIRED. THE SURGEON CONTINUED WITH IMPLANTING THE IMPLANT ALTHOUGH IT IS OFF LABEL USE. THERE IS NO FURTHER INFORMATION KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892828 MEDPOR CUSTOMIZED-MANDIBLE IMPLANT FWP STRYKER ORTHOBIOLOGICS-MALVERN 5444-0-610 2010291020 07613252457671

    Patients

    Seq Age Sex Outcome Treatment
    1 Other