BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING CAP

    MDR report key: 2809718 · Received October 19, 2012

    Report

    Report Number
    2520274-2012-02408
    Event Type
    Injury
    Date Received
    October 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAT #: IT IS UNK IF THE PT WAS IMPLANTED WITH MATRIX (CAT # 04.620.000, LOT# 6944350) OR MIRS (PART# 04.631.502). THE IMPLANTS WERE RETURNED FOR CAT # 04.620.000. THE 510K FOR CAT # 04.620.00 - K082572, 510K FOR CAT # 04.631.502 - K113044. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVAL PROCESS. INVESTIGATION IS ON-GOING; NO CONCLUSION COULD BE DRAWN. A RECALL WAS INITIATED FOR MIRS (PART # (B)(4)).

    Description of Event or Problem · 1

    PT WAS TREATED FOR AN L4 FRACTURE WITH SPINAL CANAL NARROWING. PT INSTRUMENTED DORSALLY WITH CEMENT AND MIRS AT L3-L5 ALONG WITH KYPHOPLASTY, HEMILAMINECTOMY AND TRANSPEDICULAR PE AT L4 ON (B)(6) 2012. CONSTRUCT CONSISTED OF 4 SCREWS, 4 LOCKING CAPS AND 2 RODS. ON (B)(6) 2012, PT DEVELOPED AN OSTEOPOROTIC COMPRESSION FRACTURE AT L2 AND UNDERWENT REVISION SURGERY. PT WAS CEMENTED DORSALLY WITH AN EXTENSION OF MIRS INSTRUMENTATION TO L1. EXTENSION CONSTRUCT CONSISTED OF AN ADDITIONAL 2 LOCKING CAPS, 2 SCREWS AND 2 RODS. THIS IS THE 12TH OF 14 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING CAP KTT SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention SCREW BODIES| RODS| SCREWS| LOCKING CAPS