BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TL PEDICLE SCREW DIA. 7 LG 35

    MDR report key: 8596147 · Received May 9, 2019

    Report

    Report Number
    3003853072-2019-00031
    Event Type
    Injury
    Date Received
    May 9, 2019
    Date of Event
    March 4, 2019
    Report Date
    May 24, 2019
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). ADDITIONAL INFORMATION: UDI AND METHODS, RESULTS, AND CONCLUSIONS. THE DEVICE WAS NOT RETURNED, HOWEVER, A PHOTO AND X-RAY WERE PROVIDED THAT SHOW TWO SCREWS HAVE FRACTURED POST OPERATIVE. BASED ON THE NATURE OF THE FAILURE, IT IS LIKELY THAT THE TWO SCREWS IMPLANTED ON S1 HAD LIKELY EXPERIENCED REPEATED MECHANICAL STRESSES OVER THE YEARS THAT THE DEVICES WERE IMPLANTED. A REVIEW OF THE LABELING SHOWS THIS EVENT IS SUFFICIENTLY COVERED BY THE LISTED POTENTIAL SIDE EFFECTS. A REVIEW OF THE PRODUCTION RECORDS DID NOT INDICATE ANY MANUFACTURING ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IMAGING TAKEN, IN RESPONSE TO THE PATIENT'S CLAIM OF PAIN, FOUND TWO PEDICLE SCREWS AT S1 WERE BROKEN IN THE THREADED SHAFT. A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE PEDICLE SCREWS. THE PATIENT'S PAIN DISAPPEARED AFTER THE REVISION WAS PERFORMED. THIS IS EVENT TWO OF TWO FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    UDI NUMBER: NI. THIS DEVICE IS NOT REGISTERED WITHIN THE US. HOWEVER, IT IS SIMILAR TO INSTINCT JAVA SYSTEM, NKB, K111301. 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 REPORT 3003853072-2019-00030.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMAGING TAKEN, IN RESPONSE TO THE PATIENT'S CLAIM OF PAIN, FOUND TWO PEDICLE SCREWS AT S1 WERE BROKEN IN THE THREADED SHAFT. A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE PEDICLE SCREWS. THE PATIENT'S PAIN DISAPPEARED AFTER THE REVISION WAS PERFORMED. THIS IS EVENT TWO OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387447 TL PEDICLE SCREW DIA. 7 LG 35 JAVA TOP LOADING NKB ZIMMER SPINE NA H26222A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R