BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX LOCKING CAP WITHOUT SADDLE

    MDR report key: 4171582 · Received October 14, 2014

    Report

    Report Number
    2520274-2014-14127
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    September 18, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    NKB
    PMA / PMN Number
    PK120838
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAMES: MNH, MNI, KWQ, KWP. REPORTED ONLY AS APPROXIMATELY ONE YEAR PRIOR TO THIS EVENT. 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. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A POSTERIOR LUMBAR FUSION (PLIF) CONSTRUCT WAS PERFORMED APPROXIMATELY ONE YEAR PRIOR TO THIS REPORT. THE PATIENT FELL AND REPORTED HE COULD HEAR A SQUEAKING NOISE BUT HAD NO PAIN. A REVISION WAS PERFORMED DUE TO 2 OF THE SCREWS HAD BROKEN AND THE PATIENT HAD NOT FUSED ONE YEAR POST-OPERATIVE AND WAS OF A HEALTHY WEIGHT RANGE. THIS IS REPORT 7 OF 10 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650162 MATRIX LOCKING CAP WITHOUT SADDLE ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention