BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECOR MIDLINE CEMENT STAGING OSTEOTOME

    MDR report key: 4703731 · Received April 14, 2015

    Report

    Report Number
    3006396387-2015-00004
    Event Type
    Malfunction
    Date Received
    April 14, 2015
    Date of Event
    March 27, 2015
    Report Date
    April 6, 2015
    Manufacturer
    DFINE INC.
    Product Code
    GFI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW: PN 3353, STABILIT FIRST FRACTURE KIT (BLISTER PACK), REVISION AG, LOT 140609A01 ((B)(4)). PN 3352, FIRST FRACTURE KIT, BLISTER PACK, SHORT DEVICES, REVISION AD, LOT 140430A01 ((B)(4)). PN 1688, STABILIT ER2 BONE CEMENT AND SATURATE MIXING SYSTEM, REVISION AC, LOT DF048 ((B)(4)). TRV 3476 / PN 3354, INNER TRAY ASSEMBLY, FIRST FRACTURE KIT, SHORT, BLISTER PACK (LZ FORM), REVISION AD, LOT SFK-1404-03 / R2120A ((B)(4)). PN 2482, ASSEMBLY OF VERTECOR MIDLINE CEMENT STAGING OSTEOTOME 3.0-11.5, SHORT, LZ-FORM, REVISION AB, LOT TSM-1403-31 ((B)(4)). NO ANOMALIES WERE RELATED TO THE CUSTOMER COMPLAINT (B)(4) UPON REVIEW OF THE DHR DOCUMENTATION. EVALUATION OF DEVICE: A REVIEW OF THE MATERIAL SPECIFICATIONS (B)(4), THE MATERIAL OF THE VERTECOR MIDLINE OSTEOTOME 3.0, PN3765 CONFIRMED THAT THE TIP OF THE DEVICE IS MADE FROM MEDICAL GRADE 316 STAINLESS STEEL; SIMILAR TO PEDICLE SCREWS, COMMONLY USED AS PERMANENT IMPLANTS IN FUSION SPINE SURGERY. INVESTIGATION OF THE MIDLINE OSTEOTOME CONFIRMED THE DEVICE WAS BROKEN AND THE TIP OF THE DEVICE MISSING (REMAINED IN PATIENT).

    Description of Event or Problem · 1

    WORKING IN THE ACETABULUM OF THE PELVIS IN EXTREMELY HARD BONE DUE TO PROSTATE CANCER. THE PHYSICIAN ENTERED USING THE STABILIT INTRODUCER AND BONE DRILL; THE MIDLINE OSTEOTOME WAS THEN USED TO MAKE A CHANNEL TO FOLLOW THE SPINESTAR. AFTER ADVANCING THE MIDLINE OSTEOTOME, IT BECAME STUCK. NUMEROUS TECHNIQUES WERE TRIED TO REMOVE THE MIDLINE OSTEOTOME, WITH IT FINALLY GIVING WAY AND WAS REMOVED. UPON THE REMOVAL, THE OUTER SHEATH HAD COME OFF THE MIDLINE AND WAS STILL LODGED INSIDE THE PATIENT'S BONE. A GENERAL SURGEON WAS CALLED TO ASSIST IN THE REMOVAL, WHERE A LARGER CUT IN THE PATIENT'S BUTTOCKS WAS MADE AND THE SURGEON REMOVED THE SHEATH. WHEN LOOKING THE PATIENT OVER, IT APPEARED THAT THE TIP OF THE MIDLINE OSTEOTOME WAS STILL LODGED IN THE PATIENT'S SCLEROTIC BONE LESS THAN 1-2MM, IT WAS DECIDED TO LEAVE THE PIECE INSIDE THAT PATIENT; AND THEN THE PHYSICIAN CONTINUED WITH THE ABLATION AND AUGMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249492 VERTECOR MIDLINE CEMENT STAGING OSTEOTOME OSTEOTOME GFI DFINE INC. NA TSM-1403-31

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR