BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4694053 · Received April 15, 2015

    Report

    Report Number
    2520274-2015-12888
    Event Type
    Injury
    Date Received
    April 15, 2015
    Report Date
    March 27, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. KLUG, R.A., ET AL. (2007). RUPTURE OF THE FLEXOR POLLICIS LONGUS TENDON AFTER VOLAR FIXED-ANGLE PLATING OF A DISTAL RADIUS FRACTURE: A CASE REPORT. J HAND SURG 2007;32A:984-988. THIS REPORT IS FOR UNKNOWN SYNTHES TITANIUM VOLAR DISTAL RADIUS 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

    LITERATURE ARTICLE RECEIVED: THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, KLUG, R.A., ET AL. (2007). RUPTURE OF THE FLEXOR POLLICIS LONGUS TENDON AFTER VOLAR FIXED-ANGLE PLATING OF A DISTAL RADIUS FRACTURE: A CASE REPORT. J HAND SURG 2007;32A:984-988. THIS CASE WAS REPORTED ABOUT A 59-YEAR OLD, RIGHT-HANDED FEMALE WHO HAD A FALL ONTO AN OUTSTRECHED ARM AND SUSTAINED A COMMINUTED INTRA-ARTICULAR FRACTURE OF THE LEFT DISTAL RADIUS. SHE HAD SUCCESSFUL VOLAR FIXED-ANGLE PLATING OF THE FRACTURE AT AN OUTSIDE INSTITUTION USING A SYNTHES TITANIUM VOLAR DISTAL RADIUS PLATE (ITEM NO. 442483; SYNTHES, (B)(4)). 13 MONTHS AFTER VOLAR FIXED-ANGLE PLATING OF THE FRACTURE, THE PATIENT EXPERIENCED A COMPLETE RUPTURE OF THE FLEXOR POLLICIS LONGUS TENDON. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN SYNTHES TITANIUM VOLAR DISTAL RADIUS PLATE AND REFERS TO PAIN AND WEAKNESS IN THE LEFT WRIST AND THE DEVELOPMENT OF COMPLETE INABILITY TO ACTIVELY FLEX THE INTERPHALANGEAL JOINT OF THE LEFT THUMB. IT ALSO REFERS TO A COMPLETE RUPTURE OF THE FLEXOR POLLICIS LONGUS TENDON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251915 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention