BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 8186505 · Received December 20, 2018

    Report

    Report Number
    3007700286-2018-00114
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    December 4, 2018
    Report Date
    December 11, 2018
    Manufacturer
    SI-BONE, INC.
    Product Code
    OUR
    PMA / PMN Number
    K080398
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU AND FMEA, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICES WERE OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS USER ERROR; IMPROPER IMPLANT SIZE SELECTION, USING IMPLANTS THAT WERE TOO LONG. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI/GTIN NUMBERS: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7050-100, LOT# 493438, MFD. 24 JUL 15, EXP. 2020-07-24, GTIN (B)(4). 2ND (MIDDLE): IFUSE IMPLANT, P/N 7040-100, LOT# 170874, MFD. 07 FEB 14, EXP. 2019-02-07, GTIN (B)(4). 3RD (INFERIOR): IFUSE IMPLANT, P/N 4040-100, LOT# 178970, MFD. 01 AUG 14, EXP. 2019-08-01, GTIN (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2016 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD A PREVIOUS LUMBAR FUSION. THE PATIENT HAD SI JOINT PAIN RELIEF, BUT LATER PRESENTED TO A NEW SURGEON WITH COMPLAINTS OF BUTTOCK PAIN. THE SURGEON DETERMINED THAT ALL THE IMPLANTS WERE TOO LONG AND WERE PROUD OF THE ILIUM, IRRITATING THE SURROUNDING TISSUES. THE SURGEON DID NOT INDICATE THAT ANY OF THE IMPLANTS WERE LOOSE. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED ALL THE SI JOINT IMPLANTS USING CHISELS AND REMOVED THE LUMBAR HARDWARE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024855 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention