BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 10603394 · Received September 29, 2020

    Report

    Report Number
    3007700286-2020-00084
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    February 16, 2021
    Report Date
    March 9, 2021
    Manufacturer
    SI-BONE, INC.
    Product Code
    OUR
    PMA / PMN Number
    K190230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PREVIOUS: THE PATIENT HAD ALL THREE LEFT SIDE SI JOINT IMPLANTS REMOVED IN (B)(6) 2020 DUE TO POSSIBLE METAL ALLERGIES. UPDATED: THE PATIENT HAD ALL THREE RIGHT SIDE SI JOINT IMPLANTS REMOVED IN (B)(6) 2021 DUE TO POSSIBLE METAL ALLERGIES. THE SURGEON REMOVED THE IMPLANTS WITH CHISELS AS THEY WERE SOLIDLY FIXED IN BONE. THE EXPLANT VOIDS WERE FILLED WITH BONE GRAFT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN. BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE GUIDE, IFU, CERTIFICATES OF CONFORMANCE AND FMEA, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS AN ALLERGIC REACTION TO TRACE METALS FOUND IN THE IIMPLANTS. THE IMPLANTS ARE CONTRAINDICATED FOR USE IN PATIENTS WITH ALLERGIES TO METAL COMPONENTS. IT WAS THE SURGEON'S DECISION TO REMOVE THE IMPLANTS AT THE PATIENT'S REQUEST. RIGHT SIDE IMPLANT PART NUMBERS, LOT NUMBERS, MANUFACTURING DATE, EXPIRATION DATE AND GTIN: 1ST (SUPERIOR): IFUSE-3D IMPLANT, P/N 7045M-90, LOT# 2611622, MFD. 10/02/17, EXP. 2022-10-02, GTIN 00851085007350, 2ND (MIDDLE): IFUSE-3D IMPLANT, P/N 7040M-90, LOT# 2618171, MFD. 10/21/17, EXP. 2022-10-21, GTIN 00851085007343, 3RD (INFERIOR): IFUSE-3D IMPLANT, P/N 7035M-90, LOT# 2591222, MFD. 07/05/17, EXP. 2022-07-05, GTIN 00851085007305.

    Description of Event or Problem · 0

    PREVIOUS: THE PATIENT HAD ALL THREE LEFT SIDE SI JOINT IMPLANTS REMOVED IN (B)(6) 2020 DUE TO POSSIBLE METAL ALLERGIES. UPDATED: THE PATIENT HAD ALL THREE RIGHT SIDE SI JOINT IMPLANTS REMOVED IN (B)(6) 2021 DUE TO POSSIBLE METAL ALLERGIES. THE SURGEON REMOVED THE IMPLANTS WITH CHISELS AS THEY WERE SOLIDLY FIXED IN BONE. THE EXPLANT VOIDS WERE FILLED WITH BONE GRAFT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE GUIDE, IFU, CERTIFICATES OF CONFORMANCE AND FMEA, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS AN ALLERGIC REACTION TO TRACE METALS FOUND IN THE IMPLANTS. IT WAS THE SURGEON'S DECISION TO REMOVE THE IMPLANTS AT THE PATIENT'S REQUEST. PART NUMBER, LOT NUMBER, MANUFACTURE DATE, EXPIRATION DATE AND GTIN: LEFT SIDE: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7050-90, LOT# 223222, MFD. 12/18/14, EXP. 2019-12-18, GTIN (B)(4). 2ND (MIDDLE): IFUSE IMPLANT, P/N 7040-90, LOT# 343338, MFD. 04/06/15, EXP. 2020-04-06, GTIN (B)(4). 3RD (INFERIOR): IFUSE IMPLANT, P/N 7035-90, LOT# I0A17, MFD. 05/20/14, EXP. 2019-05-20, GTIN (B)(4). RIGHT SIDE: 1ST (SUPERIOR): IFUSE-3D IMPLANT, P/N 7045M-90, LOT# 2611622, MFD. 10/02/17, EXP. 2022-10-02, GTIN (B)(4). 2ND (MIDDLE): IFUSE-3D IMPLANT, P/N 7040M-90, LOT# 2618171, MFD. 10/21/17, EXP. 2022-10-21, GTIN (B)(4). 3RD (INFERIOR): IFUSE-3D IMPLANT, P/N 7035M-90, LOT# 2591222, MFD. 07/05/17, EXP. 2022-07-05, GTIN (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD STAGED BILATERAL SI JOINT ARTHRODESIS WITH THE LEFT SIDE BEING PERFORMED IN (B)(6) 2015 AND THE RIGHT IN (B)(6) 2018. THREE IMPLANTS WERE INSTALLED ON EACH OCCASION. THE PATIENT LATER REPORTED TO A DIFFERENT SURGEON REQUESTING THAT ALL THE IMPLANTS BE REMOVED DUE TO METAL ALLERGIES. IN (B)(6) 2020, THE SURGEON REMOVED ALL THREE LEFT SIDE IMPLANTS USING CHISELS AS THEY WERE SOLIDLY FIXED IN BONE. THE SURGEON WAS UNABLE TO FREE ANY OF THE RIGHT SIDE IMPLANTS USING THE CHISELS AS THEY TOO WERE SOLIDLY FIXED IN BONE. THE SURGEON DID NOT INDICATE THAT THE IMPLANTS WERE LOOSE OR MALPOSITIONED. THE SURGEON IS CONSIDERING REFERRING THE PATIENT TO A DIFFERENT SURGEON TO REMOVE THE RIGHT SIDE IMPLANTS. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065909 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other