BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM TI VA-LCKNG CALCANEAL PL W/TABS MEDIUM 64MM LEFT-STER

    MDR report key: 10322288 · Received July 24, 2020

    Report

    Report Number
    8030965-2020-05260
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    July 6, 2020
    Report Date
    July 6, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819618411
    PMA / PMN Number
    K131186
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE: HWC. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR CALCANEUS FRACTURES BY USING THE VARIABLE ANGLE LOCKING CALCANEAL PLATE. DURING THE SURGERY, FRONT PART OF THE PLATE PROTRUDED FROM THE BONE BECAUSE THE PLATE DID NOT FIT THE BONE SHAPE AND A STRONG TENSION WAS PROBABLY APPLIED AT THE TIME OF A SURGICAL SUTURE. SKIN NECROSIS WILL POSSIBLY OCCUR AFTER THE SURGERY. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 2.7MM TI VA-LCKNG CALCANEAL PL W/TABS MEDIUM 64MM LEFT-STER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783419 2.7MM TI VA-LCKNG CALCANEAL PL W/TABS MEDIUM 64MM LEFT-STER PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH 07611819618411

    Patients

    Seq Age Sex Outcome Treatment
    1 VA-LOCKI CALCANEAL PL 2.7 MED L64 LE W/T