BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2856268 · Received December 4, 2012

    Report

    Report Number
    1030489-2012-02529
    Event Type
    Injury
    Date Received
    December 4, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED; THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE PART# 868-021, LOT 0099944W; PART #810-306, LOT 0059262W; PART 75646535, LOT UNK; PART 7560020, LOT UNK; PART 7561102, LOT UNK. (B)(6). (B)(4). THE PMA#: PART 868-021, 510K K040962; PART 75646535, 510K K042025; PART 7560020, 510K K052187; PART 7561102, 510K K031655; PART 810-306, 510K K982990. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. MANUFACTURE DATE FOR LOT 0099944W IS 4/20/2010; MANUFACTURE DATE FOR LOT 0059262W IS 10/01/2009.

    Additional Manufacturer Narrative · 1

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE PART # 868-021, LOT #0099944W; PART # 810-306, LOT # 0059262W; PART #7560020, LOT #0056648W; PART #7561102, LOT #0043539W; PART # 7561102, LOT # H09B2121; PART #75645025,LOT # H09A0710. MANUFACTURE DATE FOR LOT 0099944W IS 6/23/2010; MANUFACTURE DATE FOR LOT 0059262W IS 10/01/2009; MANUFACTURE DATE FOR LOT 0056648W IS 09/18/2009; MANUFACTURE DATE FOR LOT 0043539W IS 07/10/2009; MANUFACTURE DATE FOR LOT H09B2121 IS 02/20/2009; MANUFACTURE DATE FOR LOT H09A0710 IS 01/30/2009. ANALYSIS FOR THE BONESCREW AND CROSSLINK FOUND: VISUAL REVIEW OF THE MAS HEAD AND CROSSLINK DISCOVERED A SIGNIFICANT AMOUNT OF PITTING AND MATERIAL CORROSION PRESENT AT THE BASE OF THE HEAD, WHERE THE ROD INTERFACES. THE CORRODED AREAS APPEAR TO HAVE A SURFACE MORPHOLOGY CONSISTENT CHEMICAL ATTACK. THE LOCATION OF THE CORROSION AND PITTING IS SEEN AT AND AROUND CONSTRUCT INTERFACE POINTS. WHEN ASSEMBLED, THESE AREAS PROVIDE CREVICES WHICH CAN PROMOTE IN VIVO CORROSION. STAINLESS STEEL CORROSION RESISTANCE IS OBTAINED FROM A PASSIVE FILM WHICH FORMS IN AN OXYGEN RICH ENVIRONMENT; THE PRESENCE OF LARGE AMOUNTS OF BIOLOGICAL MATERIAL MAY HAVE GENERATED AN OXYGEN DEFICIENT REGION, RESULTING ANODIC CELL DEVELOPMENT, WHICH COULD RESULT IN THE LOSS OF THE PASSIVE FILM AND EVENTUAL CORROSION OF THE MATERIAL. ADDITIONALLY, MICRO-MOTION OR IMPLANT SURFACE DAMAGE DURING IMPLANTATION OR CONSTRUCT ASSEMBLY OF THE COMPONENTS MAY HAVE ALSO CONTRIBUTED BY MECHANICALLY REMOVING THE PASSIVE FILM FORMED ON THE STAINLESS STEEL. THE NATURE, LOCATION, LENGTH OF IMPLANTATION IN VIVO, AND CORRODED SURFACE MORPHOLOGY OF THE RETURNED IMPLANTS ARE CONSISTENT WITH ANTICIPATED IN-VIVO WEAR DUE TO CREVICE CORROSION. ANALYSIS FOR THE REMAINING PARTS FOUND: VISUAL AND OPTICAL EXAMINATION DID NOT IDENTIFY SURFACE PITTING. OPTICAL EXAMINATION DID NOT IDENTIFY MATERIAL OR FUNCTIONAL ISSUE WITH RESPECT TO THE IMPLANTS. THE IMPLANTS APPEAR TO BE CAPABLE OF PERFORMING THEIR INTENDED FUNCTION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION AT T2-L1 FOR SCOLIOSIS CORRECTION. AT 26 MONTHS POST-OP THE PATIENT UNDERWENT A REVISION SURGERY BECAUSE OF PAIN AND SUSPECTED METALOSIS AND/OR ALLERGIC REACTION TO THE HARDWARE. ALL HARDWARE WAS REMOVED, FUSION DID OCCUR. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Required Intervention