BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-M TI SACRAL SCREW POLY 6X45

    MDR report key: 3082874 · Received April 29, 2013

    Report

    Report Number
    1526439-2013-16175
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    June 4, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    KWP
    PMA / PMN Number
    PK955348
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED SCREW AT THE MACROSCOPIC LEVEL REVEALED THAT THE DEVICE BROKE AT THE TRANSITION FROM THE SCREW¿S POLYAXIAL BALL TO THE SCREW SHANK. SCANNING ELECTRON MICROSCOPY ANALYSIS FOUND THAT THE FRACTURED SURFACES EXHIBITED SMOOTH AND GRAINY/ROUGH REGIONS WHICH ARE INDICATIVE OF FATIGUE FRACTURE. THE EXISTENCE OF TWO SURFACE MORPHOLOGIES IMPLIES THAT THE FRACTURE FIRST PROPAGATED AND THEN FULL FAILURE/BREAKAGE (ROUGH REGION) TOOK PLACE PRESUMABLY WHEN THE STRENGTH OF THE REMAINING REGION DID NOT HAVE THE STRENGTH TO BEAR THE LOAD. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. A REVIEW OF THE DHR IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. ALTHOUGH NO DEFINITIVE CONCLUSIONS CAN BE MADE, THE DAMAGE IS INDICATIVE OF A FATIGUE FRACTURE. IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR AN OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE PATIENT WHO HAD BEEN IN A CAR ACCIDENT WAS SUFFERING FROM MULTIPLE RIB FRACTURE, INTERNAL BLEEDING IN THE RIGHT AND LEFT PLEURAL MEMBRANE, VERTEBRAL COMPRESSION FRACTURE IN THE 10TH DISC WITH POSTERIOR SLIP DISC, KYPHOSIS AT THE 10TH VERTEBRA LEVEL AND FRACTURE IN THE 9TH, SPINAL COMPRESSION AT THE 10TH VERTEBRA & LEFT SPINAL CANAL FRACTURE IN 10TH VERTEBRA. THE PATIENT UNDERWENT AN OPERATION ON (B)(6) 2010 AND HAD A CATHETER ON THE PLEURAL MEMBRANE TO DRAIN THE BLEEDING AND POSTERIOR SPINAL RECTIFICATION BY TITANIUM SCREWS IN THE 8TH AND 11TH VERTEBRA AND SPINAL DECOMPRESSION AT THE 9TH & 10TH VERTEBRA. THE PATIENT BECAME PREGNANT, RESULTING IN WEIGHT GAIN WHICH LED TO VERTEBRAL COMPRESSION FRACTURE AND KYPHOSIS. AFFILIATE REPORTS THIS IS THE SAME FRACTURE FROM THE ACCIDENT. THE PREGNANCY LED TO RECOMPRESSION OF THAT AREA. THE HOSPITAL HAS CONFIRMED THAT SCREWS EXPLANTED ON (B)(6) 2012 WERE BROKEN. MFG MEDWATCH REPORT 1526439-2013-13593 FILED ON (B)(4) 2013 INDICATED THAT IT WAS NOT KNOWN HOW MANY SCREWS HAD BROKEN. RECEIPT OF THE RETURNED DEVICES ON (B)(4) 2013 FOUND TWO BROKEN SCREWS. THIS MFG MEDWATCH REPORT 1526439-2013-16175 IS BEING FILED FOR THE SECOND BROKEN SCREW, ALERT DATE = (B)(4) 2013 (DATE OF RECEIPT OF THE DEVICES WHEN IT WHEN IT WAS DETERMINED THAT THERE WAS A SECOND BROKEN SCREW).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185683 M-M TI SACRAL SCREW POLY 6X45 APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP DEPUY SYNTHES SPINE AJDBZH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention