BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CORTEX SCREW SELF-TAPPING 28MM

    MDR report key: 2872597 · Received December 7, 2012

    Report

    Report Number
    1719045-2012-01289
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    November 9, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS CONDUCTED. NO LOT NUMBERS WERE PROVIDED. THIS SCREW IS WHOLE AND INTACT. THE PROFILE OF THE HEAD, TYPE OF THREAD, AND THREAD PROFILE SUGGEST THAT THIS IS A MEMBER OF THE 214.8XX FAMILY OF SCREWS. IF SO, ITS LENGTH OF 28MM WOULD MAKE THIS A 214.828. THE HEAD IS LASER ETCHED. THE PART WAS MADE PRIOR TO (B)(4) 2011. THE HEX IS LIGHTLY DAMAGED WITH DISPLACED MATERIAL AT THE TOP OF THE DRIVE. THE TOP OF THE HEAD, BAND, AND BOTTOM OF THE HEAD ARE IN GOOD CONDITION WITH LIGHT MARKINGS CONSISTENT WITH NORMAL USE. THE THREADS, FLUTES AND TIP ARE ALSO IN GOOD CONDITION. THE PERTINENT DIMENSIONS THAT WERE CHECKED ARE WITHIN SPECIFICATIONS. BECAUSE NO LOT NUMBER WAS PROVIDED NO CONCLUSION CAN BE DETERMINED FROM A MANUFACTURING STANDPOINT. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.ADDITIONAL NARRATIVE:NO X-RAYS WERE PROVIDED, BUT THE CONSTRUCT WAS ON A HUMERUS. THE TYPE OF FRACTURE WAS NOT DISCLOSED. THE CONSTRUCT HAD ALL HOLES FILLED - 8 SCREWS, 8 HOLE PLATE - AND THE PLATE WAS A BROAD PLATE. THE PLATE CONSTRUCT - BROAD PLATE, ALL HOLES FILLED - MAY HAVE BEEN TOO STIFF FOR THE NATURE OF THE FRACTURE WHICH COULD HAVE LEAD TO THE NON-UNION.(B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED WITH A LC-DCP PLATE AND 4.5MM CORTEX SCREWS FOR A RIGHT HUMERAL FRACTURE ON (B)(6) 2012. POST IMPLANT, THE PATIENT COMPLAINED OF PAIN AND X-RAYS TAKEN ON AN UNKNOWN DATE REVEALED NON-UNION AND TWO BROKEN SCREWS. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR HARDWARE REMOVAL AND REVISION TO A NARROW 9-HOLE PLATE WITH NEW SCREWS AND DBX BONE PUTTY. THE SHAFTS OF THE TWO BROKEN SCREWS WERE LEFT IN THE PATIENT. THIS REPORT IS #5 OF 9 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM CORTEX SCREW SELF-TAPPING 28MM 4.5MM CORTEX SCREW SELF-TAPPING 28MM HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention SCREWS| PLATE