BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 7719268 · Received July 25, 2018

    Report

    Report Number
    2939274-2018-53078
    Event Type
    Injury
    Date Received
    July 25, 2018
    Date of Event
    January 1, 2018
    Report Date
    July 3, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR FOUR (4) UNKNOWN PLATES/UNKNOWN LOTS. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IT IS UNKNOWN HOW MANY AND WHICH PLATES MALFUNCTIONED. IMPLANTED PLATES: 3.5MM LOW PROFILE RECONSTRUCTION PLATE 5 HOLES (PART 245.025, LOT UNKNOWN, UDI: (B)(4), 510K: K031573); 3.5MM LOW PROFILE RECONSTRUCTION PLATE 8 HOLES (PART 245.028, LOT UNKNOWN, UDI: (B)(4), 510K: K031573); 3.5MM SPRING PLATE/3 HOLES (PART 02.100.303, LOT UNKNOWN, UDI: (B)(4), 510K: K061973); 3.5MM SPRING PLATE/2 HOLES (PART 02.100.302, LOT UNKNOWN, UDI: (B)(4), 510K: K061973). 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL AND REVISION SURGERY ON (B)(6) 2018 DUE TO POST-OPERATIVE IMPINGEMENT OF PLATES IN THE FEMORAL NECK. THE PATIENT WAS INITIALLY IMPLANTED WITH TWO (2) 3.5MM LOW PROFILE RECONSTRUCTION PLATES, TWO (2) LOW PROFILE SPRING PLATES, AND EIGHT (8) 3.5MM CORTEX SCREWS ON (B)(6) 2017 DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ACETABULUM. IT IS UNKNOWN WHICH SCREWS WERE USED WITH WHICH PLATES. IT IS UNKNOWN WHICH PLATES RESULTED IN THE DEVICE MALFUNCTION. IT IS UNKNOWN HOW THE PLATE IMPINGEMENT WAS DIAGNOSED OR IF THE PATIENT HAD PAIN ASSOCIATED WITH THE MALFUNCTION. DURING THE REMOVAL PROCEDURE ALL ORIGINAL HARDWARE WAS REMOVED WHOLE AND INTACT FROM THE ACETABULUM. PATIENT DID NOT RECEIVE NEW PLATES. NEW SCREWS WERE INSERTED IN THE FEMORAL NECK AND HEAD. NO SURGICAL DELAY OR PATIENT HARM WERE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS REPORTED UNKNOWN. CONCOMITANT PARTS: WASHER 13.0MM (PART 219.99, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR FOUR (4) UNKNOWN PLATES. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559295 PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention