BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL TI SPACER 10MM X 28MM 9MM HEIGHT ¿ STERILE

    MDR report key: 7525797 · Received May 18, 2018

    Report

    Report Number
    8030965-2018-53844
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Date of Event
    April 30, 2018
    Report Date
    April 30, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICES ADDED WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PATIENT HEIGHT: 163 CENTIMETERS. PART 04.812.009S, LOT L084622: MANUFACTURING SITE: MEZZOVICO. RELEASE TO WAREHOUSE DATE: AUGUST 16, 2016. EXPIRY DATE: AUGUST 01, 2026. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF DEVICES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL MATERIAL, DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 · 0

    CONCOMITANT DEVICES REPORTED: T-PAL SPACER APPLICATOR HANDLE (03.812.001, LOT 8159300, QUANTITY 1), T-PAL SPACER APPLICATOR INNER SHAFT (03.812.003, LOT 7915848, QUANTITY 1), T-PAL SPACER APPLICATOR KNOB (03.812.004, LOT 3813002, QUANTITY 1)

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. THIS REPORT IS FOR AN UNKNOWN T-PAL CAGE/SPACER/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE HAS NOT BEEN EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER PHONE NUMBER AND EMAIL ADDRESS ARE UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PATIENT CODE (B)(4) USED FOR: IT WAS REPORTED THAT HE SURGERY WAS PROLONGED ABOUT ONE HOUR. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (T-PAL) INSERTER WAS CONNECTED TO THE CAGE AND THE CAGE WAS INSERTED IN A LOCKED POSITION. IT WAS THEN UNLOCKED AND ROTATED BUT WAS SITTING TOO LATERAL IN THE DISC SPACE. THE SURGEON TRIED TO BACK SLAP THE CAGE BACK INTO POSITION BUT IT FELL OFF THE INSERTER. THIS HAPPENED WITH THE GREEN LINE STILL SHOWING AND WITH NORMAL FORCE. THEY THEN RECONNECTED A SECOND INSERTER AND TRIED TO REPOSITION THE CAGE. THE SURGERY WAS PROLONGED ABOUT ONE HOUR. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR AN UNKNOWN T-PAL CAGE/SPACER. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369217 T-PAL TI SPACER 10MM X 28MM 9MM HEIGHT ¿ STERILE INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX OBERDORF SYNTHES PRODUKTIONS GMBH L084622

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR