BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MEDTRONIC IMPLANT

    MDR report key: 4301863 · Received December 5, 2014

    Report

    Report Number
    1030489-2014-04673
    Event Type
    Injury
    Date Received
    December 5, 2014
    Report Date
    November 7, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NKB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. CLINICAL RESULTS OF COMBINED OLIF AND MIS POSTERIOR APPROACH FOR ADULT SPINAL DEFORMITIES: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 TRANSIENT LOWER-EXTREMITY WEAKNESS AND A VERTEBRAL FRACTURE AFTER OLIF WERE OBSERVED. 28 PATIENTS UNDERWENT CORRECTION SURGERIES OF EITHER CIRCUMFERENTIAL MIS OR TWO-STAGE CMIS, HYBRID PF AND FULL-OPEN PF ACCORDING TO GLOBAL BALANCE AND PELVIC PARAMETER EVALUATION. AVE FIXED SEGMENTS WERE 7.4. THE INTRAOP BLEEDING WAS 192 AND 269ML, RESPECTIVELY. THE AVE PREOP ANGLE OF 35 DEG WERE CORRECTED TO 11DEG AT F-UP. THE AVERAGE CVA AND SVA WERE CORRECTED FROM 26 AND 73MM TO 8 AND 36MM, RESPECTIVELY. THE CLINICAL RESULTS OF COMBINED OLIF AND MIS-PF WERE ACCEPTABLE, HOWEVER, THE PREOPERATIVE ESTIMATION WHETHER SINGLE STAGE OR TWO-STAGE SURGICAL STRATEGY COULD BE REQUIRED WAS STILL UNCLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787037 UNKNOWN MEDTRONIC IMPLANT NKB MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SCREWS