BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3895564 · Received June 25, 2014

    Report

    Report Number
    2520274-2014-11700
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    April 23, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. ADDITIONAL DEVICE INFO: THIS REPORT IS FOR 1 UNKNOWN SCREW/UNKNOWN LOT. 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. DEVICE WAS 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.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE DEVICES WERE RECEIVED; ALL THE IMPLANTS SHOW NORMAL TRACES OF USE. THE SCREWS ARE HIGHLY ANGULATED, BUSHING IS DISTORTED AND PLASTICALLY. THE REPORTED COMPLAINT SITUATION USING THE RETURNED DEVICES CANNOT BE REPLICATED IN A FUNCTIONAL TEST. THE IMPLANTS / SCREWS WERE USED IN THE ILIUM, WHICH IS NOT INDICATED. IN THE SURGICAL TECHNIQUE SECTION INDICATIONS AND CONTRAINDICATIONS IT IS STATED THAT THE UNIVERSAL REDUCTION SCREW IS INTENDED TO BE USED BETWEEN T1 AND S2. THE ANGULATION AND FORCE ON THE SCREW IN THE ILIUM ARE POTENTIALLY TOO HIGH AND CAN POTENTIALLY LEAD TO THE DESCRIBED FAILURE. IT CANNOT BE DETERMINED WHETHER THE ABOVE MENTIONED FACTORS HAVE CONTRIBUTED OR CAUSED THE DESCRIBED EVENT. DEVICE WAS 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 TWO UNIVERSAL REDUCTION SCREWS HAD LOOSE HEADS POST-OPERATIVELY. PER A REVIEW OF THE X-RAYS, THE BILATERAL RODS ARE DETACHED FROM SCREW CONSTRUCT AT CAUDAL PORTION AS WELL AND ONE SET CAP APPEARS TO BE OFF AND ONE TULIP HEAD APPEARS TO BE DETACHED. THIS WAS NOTICED THIRTY-SIX DAYS AFTER IMPLANT PROCEDURE FOR A SCOLIOSIS CORRECTION PROCEDURE. A REVISION SURGERY WAS PERFORMED ON (B)(6), 2014 AND THE SCREWS WERE EXPLANTED. THE PATIENT STATUS FOLLOWING THE REVISION SURGERY IS REPORTED AS OKAY. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 6 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370761 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention