BEUDAMED
    FDA Adverse Event Summary report: N

    EQUIMATRIX CANCELLOUS (8503-06-0025)

    MDR report key: 3030522 · Received March 28, 2013

    Report

    Report Number
    2410375-2013-00002
    Date Received
    March 28, 2013
    Date of Event
    August 29, 2012
    Report Date
    March 27, 2013
    Product Code
    NPM
    PMA / PMN Number
    K111816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO TECHNICAL LIMITATIONS OF THE DATABASE IN ACCOMMODATING MORE THAN 3 SUSPECT PRODUCTS, THE FOURTH CO-SUSPECT PRODUCT BIO-MEND MEMBRANES COULD NOT BE ENTERED INTO THE DATABASE UNDER CO-SUSPECT PRODUCT. THIS CASE HAS BEEN LINKED TO (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, A SPONTANEOUS REPORT WAS RECEIVED BY A COMPANY REP FROM AN ORAL SURGERY ASSISTANT INVOLVING EQUIMATRIX. AN INITIAL REQUEST TO RETURN THE PRODUCT WAS RECEIVED BY CUSTOMER SERVICE BECAUSE THE DENTAL PROVIDER WAS DISSATISFIED WITH THE OUTCOME OF THE PRODUCT. IN FOLLOW-UP, THE ORAL SURGERY ASSISTANT STATED THAT THE DENTAL PROVIDER WAS NOT HAPPY WITH THE RESULTS AND THAT THE PRODUCT WAS INEFFECTIVE. THE REPORTER STATED THAT IT INVOLVED A FEW PTS OVER A PERIOD OF TIME AND WAS NOT A SPECIFIC LOT OR PRODUCT CODE BUT THE PRODUCT IN GENERAL. ON (B)(6) 2013, ADDITIONAL INFO WAS RECEIVED BY FACSIMILE FROM THE ORAL SURGERY ASSISTANT FORWARDED FROM THE DENTAL PROVIDER INVOLVING A TOTAL OF 7 PTS. THIS CASE INVOLVES PATIENT #2, A (B)(6) FEMALE WHO WAS A NON-SMOKER. ADDITIONAL MEDICAL HISTORY AND CONCOMITANT MEDICATION USED WERE NOT REPORTED. TEETH NUMBERS 8-11 HAD BEEN EXTRACTED YEARS AGO AND THERE WAS A LARGE DEFICIT. ON (B)(6) 2012, EQUIMATRIX LOT NUMBERS UH114111B AND UH114111B WERE USED IN ALL AREAS. GOOD CLOSURE WAS ACHIEVED. POST TREATMENT MEDICATION INCLUDED HYDROCODONE AND AMOXICILLIN (DOSE, ROUTE, FREQUENCY NOT REPORTED). EQUIMATRIX, USED IN ALL AREAS, "TENDED TO RESORB." RE-GRAFTING TOOK PLACE ON (B)(6), 2013 (DETAILS NOT PROVIDED) AND IMPLANTS HAD NOT YET BEEN PLACED. ON (B)(6), 2013, ADDITIONAL INFO WAS RECEIVED BY A COMPANY DENTAL CONSULTANT FROM THE DENTAL PROVIDER, AN ORAL AND MAXILLOFACIAL SURGEON. LUITPOLD CONSIDERED THIS INFO TO BE SERIOUS AND UNEXPECTED. THE PT PRESENTED WITH SEVERE RESORPTION OF THE ANTERIOR MAXILLA WHICH REQUIRED BONE GRAFTING IN ORDER TO ALLOW IMPLANT PLACEMENT. ON (B)(6) 2012, FOLLOWING A MIDCRESTAL INCISION AND FULL-THICKNESS MUCOPERIOSTEAL FLAP REFLECTION, THE FOLLOWING GRAFT MATERIALS WERE USED TO GRAFT THE BUCCAL AND CRESTAL AREAS OF THE ANTERIOR MAXILLA: EQUIMATRIX 1.5 GRAMS (LOT UH114111B); GEM 21S, 3 COMPLETE KITS (1.5 CC B-TCP AND 1.5 ML RHPDGF-BB); BIO-OSS, LARGE PARTICLE SIZE (AMOUNT UNK) AND BIO-MEND MEMBRANES WERE USED TO COVER THE SITE. LUITPOLD CONSIDERED ALL FOUR PRODUCTS TO BE SUSPECT PRODUCTS. GEM 21S HAS BEEN REPORTED SEPARATELY (B)(4). PRIMARY SOFT TISSUE CLOSURE WAS OBTAINED. ON (B)(6) 2013, APPROX 6 MONTHS POST-GRAFTING, THE AREA WAS OPENED WITH EVIDENCE OF NO NEW BONE FORMATION. ACCORDING TO THE DENTAL PROVIDER, HE WAS ABLE TO DISTINGUISH BETWEEN BIO-OSS AND EQUIMATRIX GRAFT PARTICLES. REPORTEDLY, SOME RESIDUAL EQUIMATRIX PARTICULATE REMAINED. HOWEVER, THE EQUIMATRIX PARTICLES HAD TURNED YELLOW AND DID NOT APPEAR "NORMAL." IN ADDITION, THE DENTAL PROVIDER FELT THAT ADDITIONAL ANTERIOR MAXILLARY BONE RESORPTION OCCURRED FOLLOWING THE (B)(6) 2012 GRAFT SO THAT THE AREA APPEARED CLINICALLY MORE COMPROMISED THAN PRIOR TO THE GRAFT PROCEDURE. ON (B)(6) 2013, (PREVIOUSLY REPORTED AS (B)(6) 2013), THE AREA WAS RE-GRAFTED WITH EQUIMATRIX AND RHPDGF-BB (AMOUNTS UNK). CLINICALLY, SOFT TISSUE HEALING HAS BEEN UNEVENTFUL. THE AREA WAS TO BE RE-EVALUATED IN 4-6 MONTHS FOLLOWING THE (B)(6) 2013 PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127388 EQUIMATRIX CANCELLOUS (8503-06-0025) NONE NPM UH114111B

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention