BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVERSE CONNECTOR D5,5 L62

    MDR report key: 7573289 · Received June 6, 2018

    Report

    Report Number
    3003853072-2018-00031
    Event Type
    Injury
    Date Received
    June 6, 2018
    Date of Event
    May 2, 2018
    Report Date
    November 7, 2018
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    PMA / PMN Number
    PNA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED CONNECTOR COMPONENTS WERE EVALUATED. THERE WERE NO PROBLEMS DETECTED ON THE ROD. ONE HOOK HAS A SCREW WHICH IS BROKEN. THE OTHER HOOK HAS A SCREW WHICH HAS BEEN ASSEMBLED UPSIDE DOWN. THE CAUSE OF THE SCREW BEING ASSEMBLED UPSIDE DOWN IS LIKELY ATTRIBUTED TO THE USER BACKING THE SCREW ALL THE WAY OUT OF THE ASSEMBLY AND ATTEMPTING TO REASSEMBLE IT. REASSEMBLY ALSO CAN LEAD TO SCREW BREAKAGE. THE LABELING WAS REVIEWED AND FOUND TO CONTAIN INSTRUCTIONS REGARDING PROPER DEVICE USAGE, INCLUDING WARNING AGAINST REMOVING THE SCREWS AND TRYING TO REINSTALL THEM. A REVIEW OF THE DHRS DID NOT IDENTIFY ANY MANUFACTURING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO FINAL DRIVER SHAFTS BROKE DURING BLOCKER INSTALLATION AND ONE TRANSVERSE CONNECTOR BROKE WHILE BEING INSTALLED DURING SURGERY. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE BLOCKER DRIVER TO TIGHTEN THE BLOCKERS BY HAND ALONG WITH AN ALTERNATIVE TRANSVERSE CONNECTOR. THE WAS A DELAY GREATER THAN 30 MINUTES ASSOCIATED WITH THIS EVENT, BUT THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT CLEARED FOR USE IN OR MARKETED WITHIN THE US. IT IS A SIMILAR PRODUCT TO THOSE CLEARED BY K111301 UNDER PRODUCT CODE NKB. 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. REFERENCE REPORTS 3003853072-2018-00029 THRU 3003853072-2018-00031.

    Additional Manufacturer Narrative · 1

    LOT NUMBER: 41759, E62017, AND 19184. THE RETURNED CONNECTOR HAS SUBCOMPONENTS WHICH ARE FROM THREE DIFFERENT LOTS. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO FINAL DRIVER SHAFTS BROKE DURING BLOCKER INSTALLATION AND ONE TRANSVERSE CONNECTOR BROKE WHILE BEING INSTALLED DURING SURGERY. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE BLOCKER DRIVER TO TIGHTEN THE BLOCKERS BY HAND ALONG WITH AN ALTERNATIVE TRANSVERSE CONNECTOR. THE WAS A DELAY GREATER THAN 30 MINUTES ASSOCIATED WITH THIS EVENT, BUT THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418555 TRANSVERSE CONNECTOR D5,5 L62 JAVA TOP LOADING NKB ZIMMER SPINE NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other