BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 6172754 · Received December 13, 2016

    Report

    Report Number
    1030489-2016-03402
    Event Type
    Injury
    Date Received
    December 13, 2016
    Report Date
    January 30, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    UDI-DI
    00885074134017
    PMA / PMN Number
    K042025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL REVIEW CONFIRMED THE IMPLANT IS FRACTURED BETWEEN APPROXIMATELY 3 THREADS FROM THE BASE OF THE BONE SCREW HEAD. OPTICAL EXAMINATION OF ADJACENT SURFACE AROUND THE POSSIBLE AREA OF CRACK PROPAGATION DID NOT IDENTIFY MATERIAL SURFACE DEFECT THAT COULD CONTRIBUTE TO CRACK PROPAGATION. FRACTURE SURFACE SEVERELY DAMAGED, LIKELY DUE TO REPEATED, CYCLIC IMPACT OF THE UPPER AND LOWER PORTIONS OF THE BONE SCREW, POST-FRACTURE. DIMENSIONAL EXAMINATION OF THE MAJOR AND MINOR DIAMETERS CONFIRMED CONFORMANCE TO PRINT SPECIFICATION. INCONCLUSIVE; THE EXTENT AND SEVERITY OF THE FRACTURE SURFACE DAMAGE RENDERS THE IMPLANT UNSUITABLE FOR FURTHER ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS NOT RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. X-RAY REVIEW REVIEW: L2-S1 POST-OP FILMS ARE PROVIDED. THERE HAS BEEN A PARTIAL L4 VERTEBRECTOMY WITH FRACTURE OF THE SEVERAL PEDICLE SCREWS. FUSION STATUS IS UNKNOWN. THERE APPEARS TO BE A PAUCITY OF BONE GRAFT WITHIN THE CAGE. THE FIT OF THE CAGE TO THE L3 AND L5 ENDPLATES ALSO APPEARS POOR, BUT THERE IS NOT MUCH SUBSIDENCE, LIKELY CAUSES ARE FAILURE OF FUSION.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A L4 DECOMPRESSION PROCEDURE AND UNDERWENT REMOVAL OF PEDICLE DUE TO SYNTRIPSIS. ON AN UNKNOWN DATE, POST-OP,SCREWS BROKE. PATIENT UNDERWENT REVISION SURGERY IN WHICH THE SCREWS WERE PARTIALLY EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820607 N/A APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H09H2547 00885074134017

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention