BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCK-CAP F/URS

    MDR report key: 3895562 · Received June 25, 2014

    Report

    Report Number
    1000562954-2014-10104
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    April 23, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: UNKNOWN. ADDITIONAL PRODUCT CODES: MNH, MNI, KWQ, KWP. LOT 8639180 AND LOT 8728330 PROVIDED; IT IS UNKNOWN WHICH ONE WAS THE COMPLAINED DEVICE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. MANUFACTURING DATE FOR LOT 8639180 IS SEP 20, 2013; MANUFACTURING DATE FOR LOT 8728330 IS NOVEMBER 15, 2013. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED FOR BOTH LOT NUMBERS PROVIDED: NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    ADDITIONAL NARRATIVE: 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 IS REPORT 9 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370719 LOCK-CAP F/URS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES MEZZOVICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention