BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5112762 · Received September 30, 2015

    Report

    Report Number
    2520274-2015-16277
    Event Type
    Injury
    Date Received
    September 30, 2015
    Report Date
    September 15, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. RATH, E., RUSSELL JR., G., WASHINGTON, W., AND CHIP, M. (2002). GLUTEUS MINIMUS NECROTIC MUSCLE DEBRIDEMENT DIMINISHES HETEROTOPIC OSSIFICATION AFTER ACETABULAR FRACTURE FIXATION. INJURY, INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED 33, 751-756. THIS REPORT IS FOR AN UNKNOWN CONTOURED SYNTHES OR ZIMMER 3.5 MM RECONSTRUCTION PLATE/UNKNOWN QUANTITY/UNKNOWN LOT. IT CAN NOT BE DETERMINED IF THE EVENT OCCURRED WITH A SYNTHES PLATE OR THAT OF A COMPETITOR. 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 LITERATURE ARTICLE: RATH, E., RUSSELL JR., G., WASHINGTON, W., AND CHIP, M. (2002). GLUTEUS MINIMUS NECROTIC MUSCLE DEBRIDEMENT DIMINISHES HETEROTOPIC OSSIFICATION AFTER ACETABULAR FRACTURE FIXATION. INJURY, INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED 33, 751-756. DURING A 9 MONTH PERIOD, 31 CONSECUTIVE PATIENTS WITH DISPLACED POSTERIOR WALL (PW) OR ASSOCIATED TRANSVERSE-POSTERIOR WALL ACETABULAR FRACTURE DISLOCATIONS WERE OPERATIVELY TREATED. IN THE STUDY, THERE WERE 21 MALES AND 10 FEMALES. THE AVERAGE AGE WAS 38 YEARS WITH A RANGE OF 15-88 YEARS. TWENTY-NINE PATIENTS WERE AVAILABLE FOR POST-OPERATIVE CLINICAL AND RADIOGRAPHIC EVALUATIONS. DURING THE SURGERY, THE PW FRAGMENT WAS REDUCED AND STABILIZED WITH CONTOURED SYNTHES OR ZIMMER 3.5 MM RECONSTRUCTION PLATES. COMPLICATIONS INCLUDE: PATIENT 23, A (B)(6) MALE WITH HETEROTOPIC OSSIFICATION CLASS II. THIS IS REPORT 8 OF 12 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN CONTOURED SYNTHES OR ZIMMER 3.5 MM RECONSTRUCTION PLATE. IT CAN NOT BE DETERMINED IF THE EVENT OCCURRED WITH A SYNTHES PLATE OR THAT OF A COMPETITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646273 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention