BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM PERIPROSTHETIC VA LCKNG SCREW/SLF-TPNG/STRDRV/14MM

    MDR report key: 4999155 · Received August 13, 2015

    Report

    Report Number
    2520274-2015-15206
    Event Type
    Injury
    Date Received
    August 13, 2015
    Report Date
    July 29, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    JDP
    PMA / PMN Number
    PK110354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF THE POSTOPERATIVE EVENT IS UNKNOWN; HOWEVER, IT REPORTEDLY OCCURRED TWO (2) TO THREE (3) WEEKS AFTER THE INITIAL PROCEDURE. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HRS AND HWC. DEVICES HAVE NOT BEEN EXPLANTED. (B)(6). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6), 2015 DURING WHICH A DISTAL FEMUR PLATE, SCREWS, AND CABLE WAS IMPLANTED TO TREAT A FEMUR FRACTURE. (A COMPETITOR'S OSTEOBIOLOGICAL PRODUCT WAS IMPLANTED AS WELL.) NO SURGICAL DELAY WAS REPORTED FOR THIS PROCEDURE. APPROXIMATELY TWO (2) TO THREE (3) WEEKS POSTOPERATIVE, A MAGNETIC RESONANCE IMAGE (MRI) WAS PERFORMED. AS A RESULT, THE PATIENT SUSTAINED A BURN. THIS REPORT IS 2 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534287 5.0MM PERIPROSTHETIC VA LCKNG SCREW/SLF-TPNG/STRDRV/14MM IMPLANT, FIXATION DEVICE, CONDYLAR PLATE JDP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention