BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDPOR TITAN OFW - MTB - LEFT

    MDR report key: 4013522 · Received August 15, 2014

    Report

    Report Number
    0008010177-2014-00213
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    STRYKER ORTHOBIOLOGICS-MALVERN
    Product Code
    FTM
    PMA / PMN Number
    K040364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AT THE MANUFACTURER. THE INVESTIGATION IS IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED, HOWEVER, DUE TO BIOHAZARD CONTAMINATION, IT COULD NOT BE PHYSICALLY EVALUATED. A PICTURE OF THE RETURNED IMPLANT WERE TAKEN TO PERFORM THE QUALITY INVESTIGATION. ACCORDING TO THE PICTURE PROVIDED THE REPORTED EVENT COULD BE CONFIRMED. THE CASE INFORMATION AND THE PICTURE RECEIVED WERE FORWARDED TO THE RESPONSIBLE QUALITY TEAM. THE MEDPOR PRODUCTS ARE MANUFACTURED BY STRYKER ORTHOBIOLOGICS - MALVERN (USA). THE FOLLOWING RESPONSE WAS RECEIVED FROM THE MANUFACTURER: IT WOULD BE IMPOSSIBLE FOR THE IMPLANT TO COMPLETELY FRACTURE LIKE THIS. SOME OF THE ¿BREAKING LINES¿ GO RIGHT THROUGH SOME OF THE CIRCLES WHICH WOULD NOT BE ANTICIPATED. THIS TYPE OF SIGNIFICANT MODIFICATION IS FAIRLY COMMON FOR AN ORBITAL FLOOR IMPLANT. THE SURGEON MOST LIKELY MADE SEVERAL OF THESE CUTS USING SURGICAL SCISSORS. DURING HANDLING HE MAY HAVE APPLIED FORCES IN BENDING SEVERAL SECTIONS OF THE IMPLANT THAT WEAKENED SOME OF THE TABS/SECTIONS OF THE IMPLANT WHICH HAD ALREADY BEEN CUT DOWN AS WELL. THESE AREAS OF THE IMPLANT (PERHAPS THE FIXATION TABS), HAVING BEEN COMPROMISED DURING HANDLING, MAY HAVE THEN SNAPPED DURING INSERTION.¿ FOR PREVIOUS CASES INVOLVING OTHER TITANIUM PLATES WITH A SIMILAR REPORTED EVENT (INTRAOPERATIVELY BROKEN TITAN PLATES) THE ROOT CAUSE COULD BE ATTRIBUTED TO BENDING OVERLOADS (BENDING BACK AND FORTH). BECAUSE THE DEVICE OF THE PRESENT CASE WAS TOO CONTAMINATED FOR PHYSICAL TESTING, DETAILED MATERIAL ANALYSIS WAS NOT POSSIBLE AND THE ROOT CAUSE COULD NOT BE CLEARLY DETERMINED. DURING THE INVESTIGATION NO INDICATION WAS FOUND FOR ANY SYSTEMATIC, DESIGN OR MANUFACTURING RELATED ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE IMPLANT BROKE IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE IMPLANT BROKE IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489370 MEDPOR TITAN OFW - MTB - LEFT IMPLANT FTM STRYKER ORTHOBIOLOGICS-MALVERN A1308050

    Patients

    Seq Age Sex Outcome Treatment
    1