BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    MDR report key: 6629073 · Received June 9, 2017

    Report

    Report Number
    1030489-2017-01494
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    May 17, 2017
    Report Date
    June 4, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    K143375
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG# 54840016540, 510K# K143375 AND (B)(4) IS APPROVED FOR SALE IN US. (B)(4).

    Additional Manufacturer Narrative · 1

    TWO LOTS OF THE SUSPECT DEVICE WAS IDENTIFIED, HOWEVER IT IS UNKNOWN WHICH ONE IS THE COMPLAINT PRODUCT. THE LOTS THAT WERE USED LOT H5296352, EXPIRATION DATE 2024-08-10; LOT H5324040, EXPIRATION DATE 2024-11-22. IMAGE REVIEW: " PRE-OP MRI AND POST OP X-RAY/CT FOR L4-5 PSF ARE SHOWN. SCREW LOOSENING AND FAILURE OF BONY FUSION ARE DEMONSTRATED. THIS IS ONLY 2 MONTHS POST OPERATIVE HOWEVER. BY REPORT THERE WAS A QUESTION OF INFECTION VS ALLERGY AS CONTRIBUTING FACTORS TO HARDWARE LOOSENING. THERE IS ALSO A LOSS OF LUMBAR LORDOSIS AND PROBABLY SAGITTAL BALANCE. ROOT CAUSE: INDETERMINATE."

    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 WITH DEGENERATIVE SPONDYLOLISTHESIS UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L4/5. REPORTEDLY, POST-OP, THE PATIENT HAD WORSENING OF THE LOW BACK PAIN. L5 SCREW LOOSENING WAS REPORTED. ON (B)(6) 2017 THE PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL OF ALL THE IMPLANTS AND THE SURGICAL SITE WAS CLEANED AS INFECTION WAS SUSPECTED. NO INFECTION WAS CONFIRMED BUT ALLERGIC REACTION IS SUSPECTED NOW NONE OF THE IMPLANTS BROKE. ALLERGY TESTING IS PLANNED ON THE PATIENT. PATIENT HAS NOT YET RECOVERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALLERGIC REACTION TO PATIENT NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411219 CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention