BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILLER, CALCIUM, SULFATE, PREFORMED PELLETS

    MDR report key: 4689266 · Received April 14, 2015

    Report

    Report Number
    2520274-2015-12639
    Event Type
    Injury
    Date Received
    April 14, 2015
    Date of Event
    November 27, 2004
    Report Date
    April 2, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). THIS REPORT IS FOR UNKNOWN POLY(L-LACTIDE-CO-GLYCOLIDE) (PLGA) COPOLYMER AND POLY(L-LACTIDE-CO-DL ¿LACTIDE) /UNKNOWN QUANTITY/UNKNOWN LOT. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE; ¿MAXILLARY AND MANDIBULAR OSTEOSYNTHESES WITH PLGA AND P(L/DL) LA IMPLANTS: A 5 YEAR INPATIENT BIOCOMPATIBILITY AND DEGRADATION EXPERIENCE.¿ (2006). LANDES, C.A., BALLON, A., AND ROTH, C. AND PLASTIC RECONSTRUCTIVE SURGERY 117:2347-2360. THIS CASE STUDY INVOLVED EIGHTY FRACTURE AND RECONSTRUCTION CASES. INCLUSION CRITERIA WERE A MAXILLARY OR MANDIBULAR FRACTURE OR RECONSTRUCTIVE PROCEDURE. OPERATIONS WERE PERFORMED FROM MAY OF 1999 TO MAY OF 2004. PATIENTS WERE AGED 1 TO 83 YEARS (AVERAGE 26 YEARS). THIRTY-TWO WERE FEMALE AND 48 WERE MALE. OSTEOSYNTHESES WERE USED AS FOLLOWS: POLY(82L-LACTIDE-CO-18GLYCOLIDE) LACTOSORB; LORENZ AND POLY(85L-LACTIDE-CO15GLYCOLIDE)(PGLA); POLYMAX-RAPID;SYNTHES, (B)(4)) IN 20 PATIENTS. POLY(70L-LACTIDE-CO-30DL-LACTIDE) COPOLYMER (P(L/DL)LA; MACROSORB; MACROPORE, SAN DIEGO, CALIF.; AND POLYMAX; SYNTHES) IN 60 PATIENTS. 30 PATIENTS HAD REVISION SURGERY; 5 PATIENTS HAD FOREIGN BODY REACTIONS: 1 PATIENT WITH SWELLING AND LOCAL DISCOMFORT. ONE PATIENT HAD DISCRETE OSTEOLYSIS WITH INSUFFICIENT OR EXCESS FORMATION OF CALLUS. LOCAL CURETTAGE AND DEBRIDEMENT WAS NECESSARY. THREE PATIENTS WITH STERILE INTRAORAL FISTULAS WITH DRAINING LACTIDE DEBRIS. ALL LESIONS SUBSIDED THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN POLY(L-LACTIDE-CO-GLYCOLIDE) (PLGA) COPOLYMER AND POLY(L-LACTIDE-CO-DL ¿LACTIDE.) A COPY OF THIS JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR TWO DEVICES. THE COUNTRIES OF ORIGIN FOR THIS ARTICLE ARE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248376 FILLER, CALCIUM, SULFATE, PREFORMED PELLETS MQV SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention