BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASY SPINE SCREW, UNKNOWN

    MDR report key: 9876070 · Received March 24, 2020

    Report

    Report Number
    3004788213-2020-00030
    Event Type
    Injury
    Date Received
    March 24, 2020
    Date of Event
    February 7, 2020
    Report Date
    June 29, 2020
    Manufacturer
    LDR MEDICAL
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN B4, G4, G7, H2, H6: METHODS, RESULTS, AND CONCLUSION CODES. THE PRODUCT WAS NOT RETURNED AND NO PHOTOS WERE PROVIDED, SO AN EVALUATION IS UNABLE TO BE PERFORMED. AS SUCH, NO EVALUATION RESULTS ARE AVAILABLE AND NO CONCLUSIONS REGARDING THE CAUSE CAN BE DRAWN. WITHOUT THE RETURNED PRODUCT, THE EVENT IS NON-VERIFIABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AN EASYSPINE CONSTRUCT FOR AN UNKNOWN REASON. THERE WAS NO FURTHER SURGICAL OR PATIENT INFORMATION PROVIDED. THIS IS REPORT TWO OF SIX FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: EASY SPINE SYSTEM OR LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASY SPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S... PMA/510(K) NUMBER: K123134 OR K121103. 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 3004788213-2020-00029 TO 3004788213-2020-00034.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AN EASY SPINE CONSTRUCT FOR AN UNKNOWN REASON. THERE WAS NO FURTHER SURGICAL OR PATIENT INFORMATION PROVIDED. THIS IS REPORT TWO OF SIX FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334322 EASY SPINE SCREW, UNKNOWN SEE H10 NKB LDR MEDICAL NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R