BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4943152 · Received July 27, 2015

    Report

    Report Number
    2520274-2015-15027
    Event Type
    Injury
    Date Received
    July 27, 2015
    Report Date
    July 14, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER IS NOT AVAILABLE FOR REPORTING. DATE OF POSTOPERATIVE NON-UNION IS UNKNOWN. THIS REPORT IS FOR THREE (3) UNKNOWN SCREWS WITH A POTENTIAL RANGE OF PARTS NUMBERS BETWEEN 209.860 AND 209.890. THE EXACT DATE OF THE INITIAL PROCEDURE IS UNKNOWN, BUT REPORTEDLY TOOK PLACE SIX (6) MONTHS EARLIER.: THE COMPLAINANT SCREWS WERE DISCARDED AND ARE NO LONGER AVAILABLE FOR RETURN. (B)(6). HOWEVER, BASED ON THE PROVIDED RANGE OF POTENTIAL PART NUMBERS, THE LIKELY 510K NUMBER IS K962011. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A CLOSED REDUCTION WITH INTERNAL FIXATION OF RIGHT NECK FOR FEMUR PROCEDURE APPROXIMATELY SIX (6) MONTHS AGO. DURING THAT PROCEDURE, 7.3MM CANNULATED SCREWS WERE IMPLANTED PERCUTANEOUSLY INTO THE FEMORAL NECK ALONG WITH AN ANGLED BLADE PLATE DUE TO A SUSTAINED MOTOR-CROSS INJURY. IT WAS LATER DISCOVERED THAT THE BONE DID NOT HEAL DUE TO A NON-UNION. THE SURGEON ATTRIBUTED THE NON-UNION TO THE BONE¿S FAILURE TO UNITE AND NOT A FAILURE OF THE SCREWS, WHICH WERE REMOVED FULLY INTACT. THE THREE (3) CANNULATED SCREWS WERE REMOVED ALONG WITH THE ANGLED BLADE PLATE. AN OSTEOTOMY WAS THEN PERFORMED TO INCREASE THE NECK ANGLE AND A PLATE WAS INSERTED (IT IS UNKNOWN IF THE ORIGINAL PLATE WAS RE-INSERTED OR IF A NEW ONE WAS UTILIZED). THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486750 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention