BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TL PEDICLE SCREW D7 LG 35

    MDR report key: 7609360 · Received June 18, 2018

    Report

    Report Number
    3003853072-2018-00046
    Event Type
    Injury
    Date Received
    June 18, 2018
    Date of Event
    May 12, 2018
    Report Date
    December 17, 2018
    Manufacturer
    ZIMMER SPINE
    Product Code
    MNI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 0

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 0

    THE RETURNED SCREW WAS EVALUATED. THE SCREW SHAFT WAS FOUND TO HAVE FRACTURED. THE CAUSE CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. A REVIEW OF THE MANUFACTURING RECORDS DID NOT FIND ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. THE LABELING WAS REVIEWED AND FOUND TO CONTAIN INSTRUCTIONS REGARDING PROPER USE AND ALSO LISTED IMPLANT FRACTURE AS A POSSIBLE SIDE EFFECT OF USING THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE TWO SCREWS WHICH WERE BROKEN POST-OPERATIVELY. THERE WERE NO REPORTED PATIENT IMPACTS ASSOCIATED WITH THE REVISION SURGERY. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS SIMILAR TO THOSE CLEARED BY K111301. THERE WAS NOT A DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THIS MALFUNCTION HAS NOT BEEN PREVIOUSLY REPORTED ON THIS OR A SIMILAR DEVICE AND IS NOT LIKELY TO LEAD TO A DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. THEREFORE, THIS EVENT IS NOT REPORTABLE. REFERENCE REPORT 3003853072-2018-00047.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE TWO SCREWS WHICH WERE BROKEN POST-OPERATIVELY. THERE WERE NO REPORTED PATIENT IMPACTS ASSOCIATED WITH THE REVISION SURGERY. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454720 TL PEDICLE SCREW D7 LG 35 JAVA TOP LOADING MNI ZIMMER SPINE NA H17080G

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R