BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIABLE ANGLE LOCKING PEG 1.8MM

    MDR report key: 4726705 · Received March 27, 2015

    Report

    Report Number
    3009996260-2015-00001
    Event Type
    Injury
    Date Received
    March 27, 2015
    Date of Event
    February 12, 2015
    Report Date
    March 27, 2015
    Manufacturer
    FLOWER ORTHOPEDICS CORPORATION
    Product Code
    HWC
    PMA / PMN Number
    K131657
    Removal / Correction Number
    3009996260-02202015-001-
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN HAS DETERMINED THAT REMOVAL IS NOT NECESSARY AND HAS DETERMINED THAT NO INJURY HAS OCCURRED AS A RESULT OF THE LOOSENED PEG. THE BONE FRACTURE WHICH THE PLATE AND SCREWS WERE INTENDED TO SUPPORT HAS HEALED NORMALLY. THE LOOSENED PEG HAD NO ADVERSE EFFECT ON THE HEALING OF THE FRACTURE; THE FRACTURE HEALED SUCCESSFULLY. FLOWER ORTHOPEDICS ORIGINALLY DETERMINED THIS EVENT TO BE NOT REPORTABLE, AS THERE WAS NO INJURY ASSOCIATED, AND NO MEDICAL INTERVENTION REQUIRED TO PRECLUDE ANY INJURY. THIS DECISION HAS SUBSEQUENTLY CHANGED, THUS THE DELAY IN REPORTING. HOWEVER, THERE IS STILL NO INJURY, AND THERE HAS STILL BEEN NO MEDICAL INTERVENTION TO PRECLUDE INJURY. FLOWER ORTHOPEDICS HAS DETERMINED THAT INJURY COULD OCCUR IN THIS INSTANCE, BUT HAS NOT YET OCCURRED.

    Description of Event or Problem · 1

    A PATIENT HAD A DISTAL RADIUS FIXATION PROCEDURE TO REPAIR FRACTURE. PHYSICIAN IMPLANTED A LOCKING PEG TO SECURE ONE OF THE SIX DISTAL LOCKING HOLES ON ONE EDGE OF THE PLATE. THIS LOCKING PEG DID NOT LOCK TO THE PLATE AT THE TIME OF SURGERY. THE PHYSICIAN DID NOT REMOVE THE UNLOCKED PEG DURING SURGERY. ALL OTHER LOCKING PEGS AND SCREWS THAT WERE IMPLANTED DID LOCK TO THE PLATE. ON 02/12/2015, FLOWER ORTHOPEDICS WAS MADE AWARE THAT DURING THE NORMAL POST-SURGICAL FOLLOW UP VISIT, THE PHYSICIAN NOTED A PEG WAS LOOSENED ON THE X-RAY IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204814 VARIABLE ANGLE LOCKING PEG 1.8MM HWC FLOWER ORTHOPEDICS CORPORATION NA NOT RECORDED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other