BEUDAMED
    FDA Adverse Event Death Summary report: N

    STRAUMANN BONECERAMIC

    MDR report key: 1741720 · Received June 28, 2010

    Report

    Report Number
    1222315-2010-00008
    Event Type
    Death
    Date Received
    June 28, 2010
    Date of Event
    May 29, 2010
    Report Date
    June 28, 2010
    Manufacturer
    BIORA AB
    Product Code
    LYC
    PMA / PMN Number
    K040646
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW INCL. STERILIZATION CONFIRMED THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. REVIEW OF THE COMPLAINTS DATABASE CONFIRMED THAT NO FURTHER COMPLAINTS HAVE BEEN REPORTED WITH THE ARTICLE AND LOT NUMBERS INVOLVED. CLINICAL EVAL OF THE REPORTED CASE CONCLUDES NO INDICATION OF CONNECTIONS BETWEEN THE STRAUMANN BONE CERAMIC USED AND THE COMPLICATIONS OR THE DEATH OF THE PT. REQUEST FOR AUTOPSY REPORT VIA CLINICIAN HAS BEEN MADE. NOT PROVIDED TO DATE.

    Description of Event or Problem · 1

    CLINICIAN REPORTS THAT PT UNDERWENT A SINUS FLOOR ELEVATION PROCEDURE ON (B) (6) 2010, USING STRAUMANN BONE CERAMIC. ACC. TO THE CLINICIAN PT DID NOT FOLLOW RECOMMENDATIONS AND APPLIED ICE PACKS FOR 6 CONTINUOUS DAYS. ON (B) (6) 2010, PT PRESENTED WITH BILATERAL EDEMA (MORE PRONOUNCED ON RIGHT SIDE). PT DID NOT CALL DENTIST WHEN IT BEGAN TO INFECT ON (B) (6) 2010. PT RETURNED ON (B) (6) 2010, WHEN ASPIRATION WAS HELD IN VESTIBULAR REGION. CONTENT CONSISTED OF BLOOD MIXED WITH PUS. TREATED WITH CLAVULIN 875 MG/2X DAY FOR 7 DAYS UNTIL RETURN. ON THIS DAYS DRAINED SECRETION. ON (B) (6) 2010, RETURNED WITHOUT EDEMA BUT CT REQUESTED RIGHT MAXILLARY SINUS AND AGAIN TREATED WITH CLAVULIN 875 MG/2X DAY. ON (B) (6) 2010, SURGICAL ACCESS ON RIGHT CANON FOSSA, SINUS IRRIGATION WITH SALINE, HYDROGEN PEROXIDE AND RIFAMYCIN. INSTALLED TUBE LATEX DRAIN SUTURED TO THE VESTIBULAR MUCOSA. PT ADMITTED TO HOSPITAL ON (B) (6) 2010, WITH SYMPTOMS OF SEPTICEMIA. SAME DAY KIDNEY FUNCTION PARALYZED, NEGATIVE TREND, MULTIPLE ORGAN FAILURE AND DIED ON (B) (6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRAUMANN BONECERAMIC SYNTHETIC BONE GRAFTING MATERIAL LYC BIORA AB T3260

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death INFUSE BONE GRAFT RHBMP7 WERE ALSO USED IN| STRAUMANN BONE CERAMIC: 070.204, LOT# W9920| PROCEDURE.| PRESCRIBED LEVOXIN 500MG/DAY FOR 7 DAYS & ICEPACK| COLLAGEN MEMBRANE BOVINO-BAUMER