BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANCELLOUSSCR SYNAPSE Ø3.5 L14 TAN

    MDR report key: 3031449 · Received April 2, 2013

    Report

    Report Number
    2530088-2013-00516
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KWP
    PMA / PMN Number
    K091689
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION COORDINATED BY SYNTHES (B)(4) REPORTS THE FOLLOWING: THE COMPLAINT CONDITION IS LIKELY THE RESULT OF DOMINANT DYNAMIC BENDING LOADS LEADING TO THE FATIGUE OF THE INVESTIGATED CANCELLOUS POLYAXIAL SCREW. THE IMPLANT HAD TO ABSORB AND NEUTRALIZE FORCES THAT MAY HAVE BEEN GREATER THAN THE TOLERABLE LOAD. FURTHER, THE INVESTIGATION FOUND NO EVIDENCE THAT WOULD SUGGEST ANY MATERIAL OR MANUFACTURING DEFECTS.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RETURNED AND THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE:DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS.THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A DEVICE HISTORY RECORS REVIEW HAS BEEN REQUESTED. THE INVESTIGATION IS ONGOING. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: PATIENT IMPLANTED ON (B)(6) 2012. CT SCAN (B)(6) 2012. SCREW BROKE C4 LEFT, DATE UNKNOWN. REVISION AND EXPLANT ON (B)(6) 2013, SCREW SHAFT WAS LEFT IN PATIENT.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133559 CANCELLOUSSCR SYNAPSE Ø3.5 L14 TAN KWP SYNTHES BRANDYWINE 6872964

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention