BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC/LOGIC JR.

    MDR report key: 3359826 · Received September 13, 2013

    Report

    Report Number
    2027754-2013-00008
    Event Type
    Injury
    Date Received
    September 13, 2013
    Date of Event
    August 14, 2013
    Report Date
    September 13, 2013
    Manufacturer
    OSTEOMED
    Product Code
    MQN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L CATALOG #: 216-0306. THE RETURNED PN 216-0307 WIRE WAS BROKEN OFF AT THE TIP WITH THE OTHER PIECE BROKEN OFF IN THE PN 216-0111 (LOGIC JR DISTRACTOR). THE LOT NUMBERS WERE NOT PROVIDED. IT WAS NOTED THAT THE ANATOMY ON THE LEFT SIDE OF THE PT'S FACE WAS CONCAVE SO THAT THE PLATE WOULD NOT SIT FLUSH WITH THE BONE. WHEN THE DOCTOR APPLIED PRESSURE TO INSERT THE SCREWS, THE WIRE ATTACHED TO THE DISTRACTOR PLATE BROKE OFF THE TIP WHERE THE WIRES MET THE PLATE. ACCORDING TO THE INFO REC'D, THE DOCTOR DID NOT THINK THE PROBLEM WAS DUE TO PRODUCT ERROR BUT TO THE ANATOMY OF THE PT. REGARDING THE ACTIVATION WIRE WHICH BROKE ON THE RIGHT SIDE OF THE FACE, IT WAS ALSO NOTED BY THE REP THAT ACCORDING TO THE DOCTOR, THE PT MAY HAVE BEEN APPLYING PRESSURE WITH A HEARING DEVICE THAT WAS NEAR THE ASPECT OF THE WIRE THAT EXITED THE SKIN NEAR THE RIGHT EAR. THE IFU STATE THAT THE DEVICE CAN BREAK OR BE DAMAGED DUE TO EXCESSIVE ACTIVITY OR TRAUMA. ALTHOUGH THE EXACT ROOT CAUSE OF THE WIRES BREAKING COULD NOT BE DETERMINED IT IS PROBABLE THAT A COMBINATION OF THE CONCAVE ANATOMY OF THE PT ALONG WITH THE PT POSSIBLY APPLYING FORCE TO THE DEVICE CAUSED THE BREAKAGE OF THE WIRES.

    Description of Event or Problem · 1

    SEVEN WIRES: 5 X 216-0307 82 MM FROM LOGIC JR TRAY AND 2 X 216-0306 72 MM FROM LOGIC EVAL TRAY BROKE WITH THE FOLLOWING SEQUENCE OF EVENTS: (B)(6) ACTIVATION WIRE 216-0307 WAS IMPLANTED ON THE RIGHT SIDE AND WENT IN FAIRLY EASILY. WHEN TRYING TO IMPLANT WIRES ON THE LEFT SIDE, FOUR OF THE WIRES BROKE 3 X 216-0307 AND 1 X 216-0306. THE DOCTOR WAS FINALLY ABLE TO GET ONE 216-0306 IMPLANTED ON THE LEFT SIDE. ON (B)(6) ACTIVATION WIRE 216-0307 WHICH WAS IMPLANTED ON THE RIGHT SIDE BROKE INSIDE THE PT'S MOUTH AT HOME. (B)(6) ACTIVATION WIRE 216-0307 WAS REMOVED AND THE DOCTOR ATTEMPTED TO IMPLANT ANOTHER 216-0307 WHICH ALSO BROKE WHILE THE DOCTOR WAS SECURING THE FINAL SCREWS ON THE PLATE. (B)(6) THE DOCTOR REMOVED THE PLATE AND BROKEN WIRE AGAIN AND PLACED ACTIVATION WIRE (216-0306) IN THE PT. (B)(6) THE WIRE PN 216-0306 WHICH WAS IMPLANTED ON (B)(6) BROKE IN THE PT. BASED ON INFO REC'D, THE DOCTOR PLANNED ON REMOVING THE WIRES AND ALLOWING THE PT TO CONSOLIDATE FOR THREE MONTHS AND GO BACK INTO SURGERY TO REMOVE THE PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461416 LOGIC/LOGIC JR. ACTIVATION WIRES MQN OSTEOMED UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention