BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

    MDR report key: 5218290 · Received November 11, 2015

    Report

    Report Number
    2520274-2015-17212
    Event Type
    Injury
    Date Received
    November 11, 2015
    Report Date
    October 28, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWQ
    PMA / PMN Number
    PK031276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INITIALS ARE (B)(6). THIS REPORT IS ONE UNKNOWN CSLP EXPANSIONHEAD SCREW, PARTIAL PART NUMBER 487.XXX. THIS PARTIAL PART NUMBER IS ASSOCIATED WITH TWO PART FAMILIES: 4.0MM TI CORTEX EXPANSIONHEAD SCREW SELF-TAPPING (LENGTH UNKNOWN), 510(K) K031276, DEVICE PRODUCT CODE-KWQ, COMMON DEVICE NAME--APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY AND; 4.35MM TI CANCELLOUS EXP HEAD SCREW/SELF-TAP (LENGTH UNKNOWN), 510(K) K031276, DEVICE PRODUCT CODE-KWQ, COMMON DEVICE NAME--APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY. UDI: UNKNOWN PART NUMBER, DATE OF ORIGINAL IMPLANT WAS REPORTED AS AN UNKNOWN DATE IN (B)(6) 2014. DEVICE REMAINS IMPLANTED IN THE PATIENT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT EXPERIENCED NECK PAIN. THE SURGEON DISCOVERED THE PATIENT WAS NOT HEALING AT LEVELS C6-C7 AND THERE WAS NONUNION. THE PATIENT SUBSEQUENTLY UNDERWENT REVISION SURGERY. ORIGINALLY THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION AT LEVELS C4 - C7 ON AN UNKNOWN DATE DURING (B)(6) 2014 USING THE SYNTHES CERVICAL SPINE LOCKING PLATE (CSLP) SYSTEM. THE PATIENT REPORTED THE POST-OPERATIVE NECK PAIN AND NONUNION WAS DISCOVERED AT LEVELS C6-C7. THE PATIENT WAS RETURNED TO OPERATING ROOM ON (B)(6) 2015 WHERE THE SURGEON PERFORMED A POSTERIOR CERVICAL FUSION USING THE SYNTHES SYNAPSE SYSTEM. NO ISSUES WERE NOTED WITH THE CSLP HARDWARE. THE ORIGINAL CSLP HARDWARE WAS NOT EXPLANTED AND REMAINS IMPLANTED IN PATIENT. THE SYNAPSE SYSTEM WAS ADDED TO ACHIEVE FUSION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO PATIENT. THIS REPORT IS FOR ONE UNKNOWN CSLP EXPANSIONHEAD SCREW. THIS REPORT IS 4 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746662 APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention