BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW, UNKNOWN TYPE OR SIZE

    MDR report key: 12388654 · Received August 30, 2021

    Report

    Report Number
    3012447612-2021-00338
    Event Type
    Injury
    Date Received
    August 30, 2021
    Date of Event
    July 30, 2021
    Report Date
    September 22, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    MNH
    PMA / PMN Number
    SEE-H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: PRODUCT WAS NOT RETURNED AND PHOTOS WERE NOT PROVIDED, SO DEVICE EVALUATION COULD NOT BE PERFORMED. POTENTIAL CAUSE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO THE TRAUMATIC EVENT EXPERIENCED BY THE PATIENT. DHR REVIEW S LOT NUMBER NOT PROVIDED, SO DHR REVIEW COULD NOT BE PERFORMED. DEVICE USE THIS DEVICE IS USED FOR TREATMENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS A POLARIS CONSTRUCT THE BROKE AFTER THE PATIENT FELL. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    510K NUMBER: UNKNOWN, BUT COULD BE SIMILAR TO K061441. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS A POLARIS CONSTRUCT THE BROKE AFTER THE PATIENT FELL. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280503 PEDICLE SCREW, UNKNOWN TYPE OR SIZE EBI 5.5 HELICAL FLANGE SPINAL SYSTEM MNH ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R