BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1870990 · Received October 8, 2010

    Report

    Report Number
    1030489-2010-01311
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 8, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    NKB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE LOT OF THE SUSPECTED DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE DEVICES IN USE ARE PART #7893080, LOT # W08K0315 AND LOT # W08E0302; PART #7892645, LOT # 0059846W; PART #7220850, LOT # 0080322W, LOT # 0094700W AND LOT # 0105806W. THE DEVICES WERE RETURNED FOR EVALUATION. MACROSCOPIC EXAMINATION OF THE IMPLANTS DID NOT REVEAL ANY FUNCTIONAL OR MATERIAL ISSUE. FILMS WERE RETURNED FOR EVALUATION WHICH FOUND X-RAYS AND SAGITAL/AXIAL MRI TAKEN OF PREVIOUS FUSION PLIF WITH SPACERS AND PEEK RODS. MRI SHOWS INCREASED SIGNAL IN BOTH T1 AND T2 IMAGES SUGGESTING SCLEROSIS OVER EDEMA. MARROW CHANGES WITH STRIATIONS ARE NOTED AT L3, L4, AND L5 NOT SEEN AT OTHER LEVELS. POSSIBLE SEROMAS NOTED BEHIND SPACERS. NO STENOSIS NOTED. RIGHT L5 SCREW SHOWS SIGNS OF LYSIS ABOUT THREADS. 510K # FOR 7893080 IS K052609; 510K # FOR 7892645 IS K050809; 510K # FOR 7220850 IS K061915. MANUFACTURE DATE FOR PART # 7893080, LOT W08K0315 IS 03/10/2008; MANUFACTURE DATE FOR PART # 7893080, LOT W08E0302 IS 05/22/2008; MANUFACTURE DATE FOR PART # 7892645, LOT 0059846W IS 10/13/2009; MANUFACTURE DATE FOR PART #7220850, LOT# 0080322W IS 02/12/2010; MANUFACTURE DATE FOR PART # 7220850, LOT# 0094700W IS 05/07/2010; MANUFACTURE DATE FOR PART # 7220850, LOT# 0105806W IS 07/16/2010. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION AT L3-5 TO TREAT SPINAL STENOSIS AND DEGENERATIVE DISC DISEASE. APPROX 2 MONTHS POST-OP AFTER LOOKING AT FILMS, IT WAS BELIEVED THAT THE PT WAS SHOWING SIGNS OF INFECTION; AND INFLAMMATION. THE PT ALSO REPORTED HAVING PAINS SIMILAR TO THE PAIN BEFORE THE SURGERY. ELEVEN WEEKS POST-OP, THE PT UNDERWENT REVISION SURGERY TO HAVE HARDWARE REMOVED AND REPLACED. NO INFECTION WAS FOUND DURING THE REVISION SURGERY. AWAITING RESULTS FROM THE CULTURES TAKEN DURING REVISION SURGERY. NO ADDITIONAL PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM UNK NKB WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention PEDICLE SCREWS| IMPLANTED:| RODS| IMPLANTED:| EXPLANTED:| EXPLANTED: