BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPLIF OBLIQUE SIZER 5 DEGRE 8MM

    MDR report key: 3315415 · Received August 23, 2013

    Report

    Report Number
    3005739886-2013-00026
    Event Type
    Injury
    Date Received
    August 23, 2013
    Date of Event
    July 20, 2013
    Report Date
    July 29, 2013
    Manufacturer
    SPINAL USA, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: EVALUATION OF RETURNED INSTRUMENT BY QUALITY AND ENGINEERING NOTED THE WELD THAT HOLDS THE SIZER HEAD TO THE SHAFT BROKE. REVIEW OF RECEIVING INSPECTION REPORTS FOUND THAT A TOTAL OF FIVE (5) UNITS OF THIS LOT WERE RECEIVED AND RELEASED FOR DISTRIBUTION IN (B)(4) 2013 WITH NO DEVIATION OR ANOMALIES. REVIEW OF COMPLAINT HISTORY DID NOT REVEAL ANY ADDITIONAL ISSUES OF THIS NATURE REPORTED FOR THIS PART NUMBER. IN AN EFFORT TO PREVENT RECURRENCE OF ISSUES OF THIS NATURE, DESIGN IMPROVEMENTS ARE IN PROCESS TO MANUFACTURE THIS INSTRUMENT AS ONE PIECE, STRENGTHENING THE TRANSITION FROM THE SHAFT TO THE HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED ON (B)(6) 2013, UPON ATTEMPT TO SIZE THE DISC SPACE THE INSTRUMENT FRACTURED AT THE NECK. THE SIZER HEAD WAS REMOVED FROM THE DISC SPACE AND ANOTHER SIZER THAT WAS READILY AVAILABLE WAS USED TO COMPLETE THE PROCEDURE WITH NO HARM TO THE PT OR DELAY TO THE PROCEDURE. THE DOCTOR INDICATED THAT THE PT HAD A NARROW DISC SPACE CAVITY BUT THAT HE DID NOT USE AN EXCESSIVE AMOUNT OF ADDITIONAL FORCE THAT SHOULD CAUSE THE SIZER TO FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413195 TPLIF OBLIQUE SIZER 5 DEGRE 8MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SPINAL USA, INC. 7839FR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R