BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-L PE-INLAY W/X-RAY MARKER SIZ L

    MDR report key: 3260189 · Received August 1, 2013

    Report

    Report Number
    8030965-2013-04553
    Event Type
    Injury
    Date Received
    August 1, 2013
    Date of Event
    July 12, 2013
    Report Date
    July 13, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MJO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE FINAL X-RAY AFTER THE ANTERIOR LUMBAR INTERBODY FUSION IMPLANT (ALIF) AND BEFORE THE PATIENT WAS CLOSED UP SHOWED AGAIN THAT THE X-RAY MARKER MIGHT NOT BE IN THE RIGHT POSITION. THE DOCTOR DECIDED THAT THEY WILL MONITOR THE PATIENT POST-SURGERY AND SHOULD IT BE SEEN THAT THE INLAY HAS MIGRATED FROM THE INFERIOR ENDPLATE, THE PATIENT WILL BE STABILIZED WITH PERCUTANEOUS PEDICLE SCREWS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE ARTICLE AND LOT NUMBER DO NOT MATCH; THEREFORE, A DEVICE HISTORY RECORDS REVIEW WAS NOT ABLE TO BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A PRO-DISC L PROSTHESIS WAS IMPLANTED FOLLOWING THE EXACT SURGICAL TECHNIQUE. AFTER THE IMPLANT HOLDER WAS REMOVED, A LATERAL X-RAY WAS TAKEN. THE X-RAY MARKER OF THE INLAY WAS OUTSIDE OF THE INFERIOR ENDPLATE OF THE PROSTHESIS. THE DOCTOR TRIED REPEATEDLY TO IMPACT THE INLAY INTO ITS DESIRED POSITION. AFTER ANOTHER X-RAY, THE MARKER STILL INDICATED THAT THE INLAY IS NOT IN THE CORRECT POSITION. THE DOCTOR THEN REMOVED THE PROSTHESIS WITH THE PDL REMOVAL SET AND REINSERTED THE PROSTHESIS. A NEW INLAY WAS USED. DOCTORS VERIFIED VISUALLY THAT THE INLAY WAS IN THE CORRECT POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360613 PRODISC-L PE-INLAY W/X-RAY MARKER SIZ L MJO SYNTHES GMBH AA2177

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention