BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-L SUP-PL SIZ M 6°

    MDR report key: 7139591 · Received December 21, 2017

    Report

    Report Number
    8030965-2017-50892
    Event Type
    Injury
    Date Received
    December 21, 2017
    Date of Event
    November 27, 2017
    Report Date
    November 27, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    MJO
    UDI-DI
    07612335113190
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NUMBER: SSX520K, SYNTHES LOT NUMBER: L043451: RELEASE TO WAREHOUSE DATE: 24.AUG.2016, EXPIRY DATE: 01.AUG.2026, MANUFACTURING SITE: (B)(4): NO NON-CONFORMANCE REPORTS (NCR¿S) S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. ADDITIONAL MEDICAL/SURGICAL INTERVENTION REQUIRED. ACCORDING TO THE X-RAY IMAGES THE COMPLAINT CONDITION CAN BE CONFIRMED. THE PART WAS NOT RETURNED. THEREFORE, A DETAILED INVESTIGATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. THE DEVICE WAS NOT EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PATIENT CODE: SURGICAL. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRST INLAY WAS DAMAGED (NOT THE SECOND INLAY AS PREVIOUSLY REPORTED ON INITIAL MW) UPON INSERTION, POSSIBLY BECAUSE THE SUPERIOR ENDPLATE WAS POSITIONED/INSERTED IN A WAY THAT IMPEDED THE PROGRESS OF THE INLAY INTO THE INFERIOR ENDPLATE. SURGEON WAS HEAVILY IMPACTING THE MEDIUM INLAY PUSHER. THEN THE SURGEON UTILIZED THE SECOND INLAY, WHICH WAS ERRONEOUSLY INSERTED INTO ENDPLATE PRIOR TO IMPLANTATION BY SURGICAL TEAM MEMBER. CONCOMITANT DEVICES REPORTED: INLAY PUSHER-MEDIUM (PART # PDL432, LOT # UNKNOWN. QUANTITY 1), DISTRACTOR 12MM (PART # PDL424, LOT # UNKNOWN, QUANTITY 1).

    Description of Event or Problem · 1

    IT WAS REPORTED ABOUT A TOTAL DISC REPLACEMENT (PRODISC L) OCCURRED ON (B)(6) 2017. A MEMBER OF THE SURGERY TEAM INCORRECTLY INSERTED AN INLAY INTO THE INFERIOR ENDPLATE COMPONENT PRIOR TO IMPLANTATION. SIZING AND KEEL CUTS WERE PERFORMED, IMPLANT PACKAGING WAS OPENED, AND THE SUPERIOR AND INFERIOR ENDPLATE DEVICES HAD BEEN IMPLANTED. A SECOND INLAY WAS DAMAGED UPON INSERTION, POSSIBLY DUE TO HEAVY IMPACTING, AS THE SUPERIOR ENDPLATE WAS POSITIONED/INSERTED IN A WAY THAT IMPEDED THE PROGRESS OF THE INLAY INTO THE INFERIOR ENDPLATE. INSUFFICIENT DISTRACTION WAS ACHIEVED TO RECONCILE ENDPLATE OBLIQUITY AND ENABLE UNIMPEDED INSERTION OF THE POLYETHYLENE INLAY. A SECOND INLAY WAS USED. THIS INLAY WAS PREVIOUSLY INCORRECTLY INSERTED INTO THE INFERIOR ENDPLATE PRIOR TO IMPLANTATION. THE SURGEON CONTINUED TO HEAVILY IMPACT THE INLAY, FLUOROSCOPY IMAGING WAS TAKEN AND CONFIRMED THE VISUAL INSPECTION OF A "GAP" AND "STEP" PRESENT AT THE INTERFACE BETWEEN THE INFERIOR ENDPLATE AND INLAY. THERE WAS OVER A 2 HOUR DELAY IN PROCEDURE. CONCOMITANT DEVICE: SPINE IMPLANT (PART/LOT UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES FOUR PARTS. THIS REPORT IS FOR A SUPERIOR ENDPLATE. THIS REPORT IS 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920074 PRODISC-L SUP-PL SIZ M 6° PROSTHESIS INTERVERTEBRAL DISC MJO OBERDORF : SYNTHES PRODUKTIONS GMBH L043451 07612335113190

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention