BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW+SS 6.0MMX32.5MM

    MDR report key: 12388445 · Received August 30, 2021

    Report

    Report Number
    3012447612-2021-00334
    Event Type
    Injury
    Date Received
    August 30, 2021
    Date of Event
    July 27, 2021
    Report Date
    December 27, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    QHP
    PMA / PMN Number
    H190005
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: PRODUCT WAS NOT RETURNED AND PHOTOS WERE NOT PROVIDED, SO DEVICE EVALUATION COULD NOT BE COMPLETED. POTENTIAL CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO UNKNOWN PATIENT OR OPERATIONAL FACTORS. DHR REVIEW: PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. DEVICE USE: THIS DEVICE IS USED FOR TREATMENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TETHER CONSTRUCT WAS REMOVED AND REPLACED WITH A FUSION CONSTRUCT FROM T3-L3 DUE TO THE PATIENT'S LACK OF FLEXIBILITY. THE INITIAL TETHER CONSTRUCT WAS FROM T5-L1. THIS IS REPORT 17 OF 20 FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: QHP. 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 3012447612-2021-00318 THROUGH 3012447612-2021-00337.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TETHER CONSTRUCT WAS REMOVED AND REPLACED WITH A FUSION CONSTRUCT FROM T3-L3 DUE TO THE PATIENT'S LACK OF FLEXIBILITY. THE INITIAL TETHER CONSTRUCT WAS FROM T5-L1. THIS IS REPORT 17 OF 20 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286451 SCREW+SS 6.0MMX32.5MM THE TETHER - VERTEBRAL BODY TETHERING SYSTEM QHP ZIMMER BIOMET SPINE INC. NA 2970360

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R