BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW ENHANCED BENT ROD TI 5.5X100MM

    MDR report key: 6079076 · Received November 4, 2016

    Report

    Report Number
    3005180920-2016-00566
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    October 6, 2016
    Report Date
    December 2, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MNI
    PMA / PMN Number
    K141988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 02 NOVEMBER 2016 THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION BASED ON THE IMAGES PROVIDED BY THE REPORTER, AND COMMENTED AS FOLLOWS: THE APPEARANCE OF THE ROD INSERTERS DOESN'T LOOK DAMAGED OR IMPAIRED. THE DIFFICULTY IN RELEASING THE ROD INSERTER FROM THE ROD IN SITU MIGHT BE RELATED TO PATIENT ANATOMY-COMPLEX POSITION OF THE INSTRUMENT, OR HIGH FORCES APPLIED. IN FACT THE EVENT DESCRIPTION REPORTS THAT "AFTER INCISION, RETRIEVED ROD AND ROD INSERTERS. BOTH ROD INSERTERS RELEASED ROD" MEANING THAT THE INSTRUMENT THEMSELVES OR THE IMPLANT (ROD) WERE NOT COMPROMISED. PERCUTANEOUS ROD INSERTION AND RELEASE IS IN GENERAL A COMPLEX MANOEUVRE AND DEPENDING ON THE POSITION, IT MIGHT BE DIFFICULT TO REMOVE THE INSTRUMENT. BATCH REVIEWS PERFORMED ON 03 NOVEMBER 2016. LOT 142186: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 FEBRUARY 2015. EXPIRATION DATE: 2020-01-15 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MIS ROD INSERTER STD - SHORT, CODE 03.52.10.0409, LOT. 1651085 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 SEPTEMBER 2016 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON ITEMS OF THE SAME LOT. MIS ROD INSERTER W/O STOP, CODE 03.52.10.0411, LOT. 1651086 (B)(4) ITEM MANUFACTURED AND RELEASED ON 31 AUGUST 2016. NO ANOMALIES FOUND RELATED TO THE PROBLEM. DEVICE NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    ON 14 NOVEMBER 2016 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: THE ROD INSERTER LOOKS SLIGHTLY DEFORMED IN THE PROXIMAL SHAFT, SUGGESTING A HIGH BENDING FORCE APPLIED TO REMOVE THE ROD. HOWEVER, THE INSTRUMENT IS COMPLETELY FUNCTIONAL AND ENGAGES/DISENGAGES THE ROD NORMALLY. AS DISCUSSED IN THE PRELIMINARY INVESTIGATION, PERCUTANEOUS ROD INSERTION CAN BE A COMPLEX MANOEUVER DEPENDING ON THE ANATOMY AND ON THE APPROACH.

    Description of Event or Problem · 1

    THE SURGEON MADE A INCISION OF EACH TOWER, INSERTED TOWERS AND SCREWS, INSERTED ROD, CONNECTED ROD WITH BOTH ROD INSERTERS, PERFORMED THE REDUCTION, TIGHTENED SET SCREWS. HE TRIED TO RELEASE ROD FROM ROD INSERTERS, BUT THEY DID NOT. THE SURGEON TRIED TO RELEASE MIS ROD INSERTER STD - SHORT WITH A PLIER AGAIN, BUT IT DID NOT. THE SURGEON CHANGED TO OPEN SURGERY, AFTER INCISION, RETRIEVED ROD AND ROD INSERTERS. BOTH ROD INSERTERS RELEASED ROD. IN ORDER TO AVOID THE SAME TROUBLE, THE ROD WAS REPLACED WITH A NEW ONE. DUE TO THIS EVENT, THE SURGERY WAS PROLONGED ABOUT 1 HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729634 PEDICLE SCREW ENHANCED BENT ROD TI 5.5X100MM BENT ROD MNI MEDACTA INTERNATIONAL SA 142186

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other