BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VITALITY SCREW

    MDR report key: 10520568 · Received September 11, 2020

    Report

    Report Number
    3012447612-2020-00520
    Event Type
    Injury
    Date Received
    September 11, 2020
    Date of Event
    August 5, 2020
    Report Date
    March 4, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE REPORTS 3012447612-2020-00517 TO 3012447612-2020-00526. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. INFORMATION ADDED TO H6: COMPONENT CODES, HEALTH EFFECT- IMPACT CODE, HEALTH EFFECT-CLINICAL CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS SUMMARY: THE COMPLAINT IS CONFIRMED FOR REVISION SURGERY DUE TO PSEUDOARTHROSIS. MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. DEVICE EVALUATION: PRODUCT WAS NOT RETURNED SO A DEVICE EVALUATION COULD NOT BE PERFORMED. POTENTIAL CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO PATIENT CONDITIONS, TRAUMATIC EVENT, OR FACTORS FROM THE OPERATION OR PRODUCT THAT WERE NOT PROVIDED BY THE COMPLAINANT. DHR REVIEW AND RELATED ACTIONS: DHR REVIEW COULD NOT BE PERFORMED DUE TO LACK OF LOT INFORMATION. NO ACTIONS REQUIRED. DEVICE USE: THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED THAT CHANGES THE INFORMATION PROVIDED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO PSEUDOARTHROSIS. THERE WAS NO FURTHER SURGICAL OR PATIENT INFORMATION PROVIDED. THIS IS REPORT FOUR OF TEN FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER: K171907 OR K150896. 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. REFERENCE REPORTS 3012447612-2020-00517 TO 3012447612-2020-00526.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO PSUEDOARTHROSIS. THERE WAS NO FURTHER SURGICAL OR PATIENT INFORMATION PROVIDED. THIS IS REPORT FOUR OF TEN FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983964 UNKNOWN VITALITY SCREW VITALITY SPINAL FIXATION SYSTEM NKB ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R