BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION BONE

    MDR report key: 5113411 · Received September 30, 2015

    Report

    Report Number
    2520274-2015-16328
    Event Type
    Injury
    Date Received
    September 30, 2015
    Report Date
    September 17, 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

    WERLE, A., TSUE, T., TOBY, E., AND GIROD, D. (2000). OSTEOCUTANEOUS RADIAL FOREARM FREE FLAP: ITS USE WITHOUT SIGNIFICANT DONOR SITE MORBIDITY. OTYLARYNOLOGY - HEAD AND NECK SURGERY 123(6) 711-717. THIS REPORT IS FOR AN UNKNOWN AO PLATE (DYNAMIC COMPRESSION PLATE OR LOW-CONTACT COMPRESSION PLATE)/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 SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: WERLE, A., TSUE, T., TOBY, E., AND GIROD, D. (2000). OSTEOCUTANEOUS RADIAL FOREARM FREE FLAP: ITS USE WITHOUT SIGNIFICANT DONOR SITE MORBIDITY. OTYLARYNOLOGY - HEAD AND NECK SURGERY 123(6) 711-717. THIS IS A RETROSPECTIVE REVIEW OF 54 PATIENTS UNDERGOING OSTEOCUTANEOUS RADIAL FOREARM FREE FLAP RECONSTRUCTION OF THE HEAD AND NECK. 52 UNDERWENT PROPHYLACTIC PLATING OF THEIR DONOR RADII. THIRTY PATIENTS WERE MALE, 24 WERE FEMALE. AGES RANGED FROM 16-89 YEARS WITH A MEAN OF 62 YEARS. THE FOLLOWING COMPLICATIONS WERE REPORTED: FIVE PLATED PATIENTS EXPERIENCED DONOR RADII FRACTURES. FOUR OF THE FIVE FRACTURES WERE AT THE SCREW SITE. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN AO PLATE (DYNAMIC COMPRESSION PLATE OR LOW-CONTACT COMPRESSION PLATE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646106 PLATE, FIXATION BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention