BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENOR SPINAL SYSTEM

    MDR report key: 1938251 · Received December 27, 2010

    Report

    Report Number
    1030489-2010-01644
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    May 28, 2010
    Report Date
    December 1, 2010
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MACROSCOPIC EXAMINATION CONFIRMS BONE SCREW BROKEN APPROXIMATELY 28MM FROM THE TOP OF THE SCREW. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACES REVEALED A FAIRLY FLAT FRACTURE, WITH PROGRESSIVE STRIATIONS INDICATIVE OF FATIGUE UNTIL ULTIMATE FAILURE OF THE IMPLANT, CONSISTENT WITH FAILURE DUE TO HIGH-CYCLE FATIGUE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 806R55L40T, 510K # K022191 WAS CLEARED IN THE UNITED STATES. DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. IT IS REPORTED THAT FUSION OCCURRED THEREFORE THE DEVICE MET ITS INTENDED FUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE DUE TO L2 BURST FRACTURE AFTER A FALL FROM A SECOND FLOOR OF A BUILDING AT L1-L3. DURING THE FOLLOW-UP VISIT APPROXIMATELY 15 MONTHS POST OP, IT WAS FOUND THAT BOTH L3 PEDICLE SCREWS HAD BROKEN. THE PATIENT STATED THAT SHE HEARD A POP-UP SOUND BEFORE THE VISIT WHEN SHE HAD ANOTHER FALL POST OP. THERE WAS NO SYMPTOM REPORTED AFTER THE BROKEN SCREWS WERE FOUND. FUSION REPORTED OCCURRED, THEREFORE THE REMOVAL SURGERY WAS PERFORMED APPROXIMATELY 22 MONTHS POST THE IMPLANTATION. THE CONSTRUCT WAS REMOVED DURING THE REMOVAL PROCEDURE, HOWEVER THE TIPS OF THE BROKEN SCREWS COULD NOT BE REMOVED FROM THE BONE. NO OTHER PATIENT COMPLICATIONS WERE REPORTED POST THE REMOVAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENOR SPINAL SYSTEM KWP WARSAW ORTHOPEDIC, INC. NA W08F1023

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Other| R CONNECTOR