BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEED TITAN 20X20X20MM IMPLANT

    MDR report key: 6194063 · Received December 21, 2016

    Report

    Report Number
    1649263-2016-10004
    Event Type
    Injury
    Date Received
    December 21, 2016
    Report Date
    November 30, 2016
    Manufacturer
    BIO MEDICAL ENTERPRISES INC
    Product Code
    JDR
    PMA / PMN Number
    K142292
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE/DATE OF BIRTH, GENDER AND WEIGHT ARE UNKNOWN. (B)(4). DEVICE HAS REPORTEDLY NOT BEEN EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPEED TITAN 20X20X20 MM IMPLANT THAT WAS ORIGINALLY IMPLANTED ON (B)(6) 2016 BROKE THREE MONTHS POST OPERATIVELY. THE PATIENT WAS CASTED AND NON-WEIGHT BEARING INITIALLY POSTOPERATIVELY. THE BROKEN STAPLE (TOP STAPLE OF TWO) WAS DISCOVERED ON X-RAYS. THE STAPLE BROKE AFTER THE BONES WERE FUSED AND THE PATIENT WAS WEIGHT BEARING. THE PATIENT IS NON-SYMPTOMATIC WITH NO PAIN; THEREFORE, THE STAPLE WILL REMAIN IN THE PATIENT AND WILL NOT BE REMOVED. NO FURTHER ACTION IS PLANNED. THE PROVIDED X-RAYS WERE REVIEWED BY THE MANUFACTURER AND IT WAS NOTED THAT THEMORE DORSAL (TO THE LEFT) STAPLE IS BROKEN IN TWO PLACES (AT EACH CURVE/ELBOW OF THE STAPLE). JOINT UNION COULD NOT BE DETERMINED BY THE PROVIDED THE X-RAYS. CONCOMITANT DEVICE REPORTED: SPEED TITAN 20X20X20 MM IMPLANT (PART SE-2020TI, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845006 SPEED TITAN 20X20X20MM IMPLANT BONE STAPLE JDR BIO MEDICAL ENTERPRISES INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1 PART SE-2020TI, LOT UNKNOWN, SPEED TITAN IMPLANT