BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5678042 · Received May 25, 2016

    Report

    Report Number
    1030489-2016-01515
    Event Type
    Injury
    Date Received
    May 25, 2016
    Report Date
    July 1, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL, MICROSCOPIC, AND SEM EXAMINATION NOTED FRACTURE SURFACE SMEARING. NO INDICATION OF FATIGUE WAS IDENTIFIED, WITH RIVERLINES AND MATERIAL DISRUPTION CONSISTENT WITH MECHANICAL OVERLOAD. DIMENSIONAL INSPECTION OF ROD DIAMETER CONFIRMS CONFORMANCE TO PRINT SPECIFICATION. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MECHANICAL OVERLOAD. 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

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 1475005085, 510K # K102807 WAS CLEARED IN THE UNITED STATES. (B)(4) (PSEUDARTHROSIS (FAILED FUSION)). PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE R EPORTED EVENT. HOWEVER, APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, WHOSE REVIEW IS AS FOLLOWS: "L3-5 MINIMALLY INVASIVE STABILIZATION OF AN L4 FRACTURE. NO INTERBODY DEVICE IS PRESENT, SUSPECT THIS WAS DONE AS AN 'INTERNAL BRACE' FOR PATIENT MOBILIZATION. NO FUSION IS PRESENT. SMALL SCREWS ARE PRESENT AT L4. THIS IS AN EXPECTED RESULT WITH STABILIZATION WITHOUT FUSION ACROSS A MOTION SEGMENT LIKE L4." 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

    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 POSTERIOR SPINAL FUSION AT L3 - L5 FOR COMPRESSION FRACTURE AT L4 WITH THE USE OF THE MEDICAL DEVICE (SPINAL SCREWS AND SPINAL ROD). POSTOPERATIVELY, ON AN UNKNOWN DATE, THE SPINAL ROD BROKE. REPORTEDLY, BONE UNION WAS ALSO NOT ACHIEVED. REVISION WAS PERFORMED ONLY FOR REMOVAL OF THE DEVICE. THE REASON FOR REVISION SURGERY WAS REPORTED UNKNOWN BUT IT WAS CERTAINLY NOT FOR ROD BREAKAGE, AS IT WAS ONLY DURING REMOVAL SURGERY, WHERE IT WAS FOUND THAT THE ROD WAS BROKEN AT THE INFERIOR PART OF L4 ON THE LEFT SIDE. IT HAD NOT BEEN FOUND BY X-RAY OR CT. NO FRAGMENTS OF THE PRODUCT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333788 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0183620W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other