BEUDAMED
    FDA Adverse Event Injury Summary report: N

    USS NUT F/USS-VAR-AXIS-SCR USS-PEDICSCR+

    MDR report key: 3033587 · Received April 3, 2013

    Report

    Report Number
    2520274-2013-01811
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 23, 2013
    Report Date
    March 7, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K992739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.THE PRODUCT WAS RETURNED AND THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURER DETERMINED FROM RECEIPT OF LOT NUMBER. INVESTIGATION COORDINATED BY (B)(4). REPORT RECEIVED INDICATES THAT THE SLEEVES AND HOOKS WERE BROKEN OFF BEFORE PUT IN POSITION. THE ROD MAY NOT HAVE BEEN POSITIONED ACCORDINGLY IN THE SCREW HEAD WHICH MAY HAVE LED TO THE BREAKAGE OF THE HOOK AND SLEEVE DURING ROD REDUCTION. THE IMPLANTS WERE MANUFACTURED ACCORDING TO THE SPECIFICATION. CORRECTED DATA: PRO CODE: MNH, MNI.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PROCEDURE, SURGEON WAS USING THE COMPRESSION FORCEPS AND ENSURED THE LOOSE NUT BEFORE COMPRESSING AGAINST THE POINT OF FIXATION, THE SLEEVE WAS BROKEN BEFORE HE PUT IT IN THE DESIRED POSITION, HE TRIED WITH A SECOND SLEEVE WITH THE SAME RESULT; THE SECOND SLEEVE WAS BROKEN AGAIN, AND THE USS LAMINA HOOK WAS BROKEN TOO. DEVICES WERE DAMAGED BEFORE THE PHYSICIAN COULD USE INTO THE PATIENT. THIS IS 1 OF 3 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS 1OF 3 REPORT FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS 1 OF 4 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136946 USS NUT F/USS-VAR-AXIS-SCR USS-PEDICSCR+ NKB SYNTHES GMBH 8091623

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention