BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIVOX¿ OBLIQUE LATERAL SPINAL SYSTEM

    MDR report key: 5619284 · Received April 29, 2016

    Report

    Report Number
    1030489-2016-01220
    Event Type
    Injury
    Date Received
    April 29, 2016
    Date of Event
    March 31, 2016
    Report Date
    April 4, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MAX
    PMA / PMN Number
    K152277
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: (PRODUCT ID: 2111160, QTY: 2) AND (PRODUCT ID: 2153214, QTY: 1). ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT OLIF (OBLIQUE LUMBAR INTERBODY FUSION) AND ANTERIOR INSTRUMENTATION FOR DEGENERATIVE DISC DISEASE/ DEGENERATIVE SCOLIOSIS FROM L3 TO S1. APPROXIMATELY TEN (10) DAYS POSTOPERATIVELY, THE PATIENT REPORTED THE EVENT OF LUMBAR DEEP WOUND INFECTION ((B)(6)). APPROXIMATELY SIX (6) DAYS POSTOPERATIVELY, THE PATIENT WAS ADMITTED INPATIENT WITH LEFT UPPER EXTREMITY, STROKE WAS RULED OUT VIA A MRI. TREATMENT INCLUDED INFECTIOUS DISEASE CONSULT FOR LUMBAR INFECTION "(B)(6)". AN IRRIGATION AND DEBRIDEMENT SCHEDULED FOR (B)(6) 2016. THE OUTCOME OF THIS EVENT IS NOT RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROPRIATELY ONE (1) MONTH POSTOPERATIVELY, THE INVESTIGATOR REPORTED RIGHT UPPER EXTREMITY SWELLING AND PAIN STARTED ON (B)(6) 2016. THE SUBJECT WAS HOSPITALIZED ON (B)(6) 2016. THE SUBJECT WAS DIAGNOSED WITH RIGHT UPPER EXTREMITY DEEP VEIN THROMBOSIS. PRIOR TREATMENT INCLUDED IV ANCEF 20 FOR A (B)(6) WOUND INFECTION (AE 1). THE INVESTIGATOR REPORTED NO VENOUS RETURN IN PICC LINE. THE INVESTIGATOR NOTED THE EVENT WAS NOT RELATED. THE OUTCOME OF THIS EVENT NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276054 PIVOX¿ OBLIQUE LATERAL SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention