BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI PARALLEL CONNECTOR 5.0MM/6.0MM

    MDR report key: 3802500 · Received May 9, 2014

    Report

    Report Number
    2520274-2014-11373
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    March 9, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    MDI
    PMA / PMN Number
    PH030009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PT IDENTIFIER: PATIENT'S INITIALS: (B)(6). DATE OF EVENT: UNKNOWN. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. 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 A REVISION SURGERY WAS PERFORMED DUE TO A TITANIUM PARALLEL CONNECTOR THAT BECAME LOOSE ON THE ROD. THE PATIENT WAS ORIGINALLY TREATED WITH A VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB AT T3 TO THE PELVIS FOR SCOLIOSIS ON (B)(6) 2014. ON AN UNKNOWN DATE, THE PATIENT¿S MOTHER DISCOVERED THAT THE PATIENT¿S BACK WAS NOT NEUTRAL. THE PATIENT VISITED THE SURGEON ON AN UNKNOWN DATE AND IT WAS CONFIRMED VIA CT SCAN THAT THE PARALLEL CONNECTOR LOOSENED FROM THE S-HOOK TO THE DISTAL EXTENSION. IT WAS REPORTED THAT THE SURGEON STATED THAT THE CONNECTOR WAS NOT TIGHT ENOUGH. THE SURGEON REPLACED THE LOOSENED CONNECTOR AND SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281810 TI PARALLEL CONNECTOR 5.0MM/6.0MM PROSTHESIS, RIB REPLACEMENT MDI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention