BEUDAMED
    FDA Adverse Event Death Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 8047355 · Received November 7, 2018

    Report

    Report Number
    8030965-2018-58007
    Event Type
    Death
    Date Received
    November 7, 2018
    Date of Event
    June 14, 2016
    Report Date
    November 1, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DIED AT 277 DAYS POSTOPERATIVELY DUE TO OSTEOMYELITIS IN THE 10TH THORACIC VERTEBRA; EXACT DATE OF DEATH IS UNKNOWN. 510K: THIS REPORT IS FOR ONE (1) UNKNOWN SYNTHES MATRIXRIB SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CARAGOUNIS EC, OLSEN MF, PAZOOKI D, GRANHED (2016). SURGICAL TREATMENT OF MULTIPLE RIB FRACTURES AND FLAIL CHEST IN TRAUMA: A ONE-YEAR FOLLOW-UP STUDY. WORLD JOURNAL OF EMERGENCY SURGERY. PAGE 1-7. (SWEDEN) HTTPS://DOI.ORG/10.1186/S13017-016-0085-2. THE AIM OF THIS PROSPECTIVE STUDY WAS TO EXAMINE THE LONG-TERM PATIENT OUTCOMES ASSOCIATED WITH PAIN, PHYSICAL FUNCTION, QUALITY OF LIFE (QOL) AND LUNG FUNCTION AFTER SURGICAL STABILIZATION OF MULTIPLE RIB FRACTURES OR FLAIL CHEST. INITIALLY, THERE WERE 60 PATIENTS WHO UNDERWENT SURGICAL FIXATION OF MULTIPLE RIB FRACTURES AS A RESULT OF BLUNT TRAUMA DURING THE PERIOD 2010 TO 2013. THESE PATIENTS WERE IMPLANTED WITH AN UNKNOWN SYNTHES MATRIXRIB FIXATION SYSTEM CONSISTING OF PRESHAPED ANGULAR LOCKED PLATES IN TITANIUM AND INTRAMEDULLARY SPLINTS THAT WAS USED TO STABILIZE RIB FRACTURES. 6 PATIENTS WERE EXCLUDED FROM THE FOLLOW-UP STUDY AS 2 PATIENTS DIED DURING THE IMMEDIATE POSTOPERATIVE PERIOD DUE TO MULTIPLE ORGAN SYSTEM FAILURE AND RESPIRATORY INSUFFICIENCY WHILE 4 PATIENTS HAD CONCOMITANT INJURIES RESULTING IN TETRAPLEGIA IN 1 PATIENT AND SEVERE HEAD INJURY IN 3 PATIENTS. THUS, A TOTAL OF 54 PATIENTS WERE INCLUDED IN THE FOLLOW-UP STUDY. THERE WERE 40 MEN AND 14 WOMEN WITH A MEDIAN AGE OF 57 YEARS (RANGE, 20-86 YEARS). THERE WERE 49 PATIENTS WHO PARTICIPATED WHILE 5 WERE LOST TO FOLLOW-UP. FOLLOW-UPS WERE DONE AT 6 WEEKS, 3 MONTHS, 6 MONTHS AND 1 YEAR POST-OPERATIVELY USING A STANDARDIZED QUESTIONNAIRE CONCERNING PAIN, LOCAL DISCOMFORT, BREATHLESSNESS AND ANALGESICS, AND QOL ACCORDING TO EQ-5D-3 L. PHYSICAL FUNCTION WAS ESTIMATED BY USING THE DISABILITY RATING INDEX (DRI) QUESTIONNAIRE WHERE 100 IS THE WORST POSSIBLE OUTCOME AND 0 IS THE BEST. COMPLICATIONS WERE REPORTED AS FOLLOWS: 24 PATIENTS WERE ON A VENTILATOR AT 24 HOURS POSTOPERATIVELY. 12 PATIENTS COMPLAINED OF PAIN AT REST DURING 6 WEEKS FOLLOW-UP, 4 PATIENTS DURING 3 MONTHS FOLLOW-UP, 6 PATIENTS DURING 6 MONTHS FOLLOW-UP AND 6 PATIENTS DURING THE 1-YEAR FOLLOW-UP. 8 PATIENTS COMPLAINED OF PAIN ON BREATHING DURING 6 WEEKS FOLLOW-UP, 5 PATIENTS DURING 3 MONTHS FOLLOW-UP, 3 PATIENTS DURING 6 MONTHS FOLLOW-UP AND 4 PATIENTS DURING THE 1-YEAR FOLLOW-UP. 14 PATIENTS COMPLAINED OF LOCAL DISCOMFORT DURING 6 WEEKS FOLLOW-UP, 17 PATIENTS DURING 3 MONTHS FOLLOW-UP, 19 PATIENTS DURING 6 MONTHS FOLLOW-UP AND 21 PATIENTS DURING THE 1-YEAR FOLLOW-UP. 14 PATIENTS COMPLAINED OF BREATHLESSNESS DURING 6 WEEKS FOLLOW-UP, 12 PATIENTS DURING 3 MONTHS FOLLOW-UP, 10 PATIENTS DURING 6 MONTHS FOLLOW-UP AND 7 PATIENTS DURING THE 1-YEAR FOLLOW-UP. 18 PATIENTS HAD ANALGESIA USAGE DURING 6 WEEKS FOLLOW-UP, 13 PATIENTS DURING 3 MONTHS FOLLOW-UP, 5 PATIENTS DURING 6 MONTHS FOLLOW-UP AND 4 PATIENTS DURING THE 1-YEAR FOLLOW-UP. UNKNOWN PATIENTS HAD EXPERIENCED PROBLEMS WITH MOBILITY, SELF-CARE, AND PERFORMANCE OF USUAL ACTIVITIES. UNKNOWN PATIENTS HAD DECREASED BREATHING MOVEMENTS ON THE OPERATED SIDE OF THE THORAX AT 3 MONTHS POSTOPERATIVELY. 1 PATIENT DEVELOPED OSTEOMYELITIS AND UNDERWENT REVISION WITH PLATE EXTRACTION AT 7 MONTHS POST-OPERATIVELY WHICH RESULTED IN THE CESSATION OF INFECTION. 1 PATIENT HAD A REVISION DUE TO LOCAL PAIN AT THE SITE OF A PROTRUDING PLATE WHEN PRACTICING HIS SPORT. 4 PATIENTS UNDERWENT 2 RE-OPERATIONS DUE TO DEEP WOUND INFECTION AND HAD SUBJECTIVE SYMPTOMS FROM PROTRUDING PLATE. 1 PATIENT HAD A LOOSE SCREW ON THE PLATE. THE PATIENT DOES NOT HAVE CLINICAL SYMPTOMS AND WAS NOT REVISED. 1 PATIENT HAD A LOOSE INTRAMEDULLARY SPLINT ON CHEST X-RAYS AT 6 WEEKS POST-OPERATIVELY. THE PATIENT DOES NOT HAVE CLINICAL SYMPTOMS AND WAS NOT REVISED. 1 PATIENT DIED AT 65 DAYS POSTOPERATIVELY DUE TO CARDIAC ARREST. 1 PATIENT DIED AT 137 DAYS DUE TO COMPLICATIONS OF CHRONIC OBSTRUCTIVE LUNG DISEASE (COPD). 1 PATIENT DIED AT 277 DAYS POSTOPERATIVELY DUE TO OSTEOMYELITIS IN THE 10TH THORACIC VERTEBRA. THIS REPORT IS FOR 1 PATIENT WHO DIED AT 277 DAYS POSTOPERATIVELY DUE TO OSTEOMYELITIS IN THE 10TH THORACIC VERTEBRA. THIS REPORT IS FOR UNKNOWN SYNTHES MATRIXRIB SCREWS. THIS IS REPORT 8 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888969 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Death