BEUDAMED
    FDA Adverse Event Injury Summary report: N

    USS LOW PROFILE FRACTURE CLAMP

    MDR report key: 4190898 · Received October 21, 2014

    Report

    Report Number
    2520274-2014-14245
    Event Type
    Injury
    Date Received
    October 21, 2014
    Report Date
    September 24, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    NKB
    PMA / PMN Number
    PK082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) 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 PATIENT ID: (B)(6). (B)(4). LOT NUMBER 3803125 THAT WAS SUPPLIED, IS AN INVAIED LOT NUMBER. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED WITH A SPINE BURST FRACTURE AT LEVEL L1. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2014. DURING INITIAL PROCEDURE THE SURGEON WENT IN WITH THE IMPRESSION THAT AN ANTERIOR FUSION MAY BE NEEDED AS WELL; HOWEVER, ONLY A POSTERIOR FUSION WAS PERFORMED. SURGEON USED IMPLANTS FROM THE UNIVERSAL SPINE SYSTEM FRACTURE SYSTEM; RODS, SCREWS AND CLAMPS AT T12 - L2 LEVELS. POST OPERATIVELY THE PATIENT¿S DISK COLLAPSED AT L1 OVER THE NEXT MONTH. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2014. IT WAS REPORTED THAT DURING REVISION SURGERY, FOUR SCHANZH SCREWS HAD PULLED OUT AT T12- L2 LEVELS FROM THE ORIGINAL CONSTRUCT. PATIENT WAS REVISED AT T12-L2 LEVELS WITH EXPEDIUM PEDICEL SCREWS AND RODS WITH EXPANDABLE LATERAL CAGE PLACED AT L1 LEVEL. REVISION SURGERY WAS COMPLETED SUCCESSFULLY AND PATIENT STATUS OUTCOME WAS GOOD. THIS IS REPORT NUMBER 7 OF 18 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668994 USS LOW PROFILE FRACTURE CLAMP ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES MEZZOVICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention