BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 6754127 · Received July 31, 2017

    Report

    Report Number
    2520274-2017-12001
    Event Type
    Injury
    Date Received
    July 31, 2017
    Report Date
    July 20, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. VAISHYA, R; AGARWAL A; GUPTA, N; VIJAY, V (2016) PLATE AUGMENTATION WITH RETENTION OF INTRAMEDULLARY NAIL IS EFFECTIVE FOR RESISTANT FEMORAL SHAFT NON-UNION. JOURNAL OF ORTHOPAEDICS, 13: 242-245. THIS REPORT IS FOR AN UNKNOWN LCDCP (UNKNOWN QUANTITY/UNKNOWN LOT). (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. (B)(4). 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

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLES: VAISHYA, R; AGARWAL A; GUPTA, N; VIJAY, V (2016) PLATE AUGMENTATION WITH RETENTION OF INTRAMEDULLARY NAIL IS EFFECTIVE FOR RESISTANT FEMORAL SHAFT NON-UNION. JOURNAL OF ORTHOPAEDICS, 13: 242-245. THIS IS A RETROSPECTIVE STUDY OF 16 PATIENTS WITH FEMORAL SHAFT NON-UNION, WHICH WERE TREATED BY PLATE AUGMENTATION AND BONE GRAFTING (IF NEEDED) WITH RETENTION OF THE INTRAMEDULLARY INTERLOCKING NAIL IN SITU. IN 12 CASES, A PRIOR DYNAMISATION WAS DONE, AND IN OTHER 4 CASES, NO PROCEDURE WAS DONE AFTER THE PRIMARY SURGERY. THESE FRACTURES PROGRESSED TO NON-UNION. INTRAOPERATIVELY, WE NOTICED ROTATIONAL INSTABILITY AT THE FRACTURE SITE IN ALL CASES. THE FIXATION OF FRACTURE WAS DONE WITH A 6¿10 HOLES, 4.5 MM TITANIUM (LOCKING) LOW CONTACT DYNAMIC COMPRESSION PLATE (LCDCP, SYNTHESTM), USING MOSTLY UNICORTICAL SCREWS AND WHEREVER POSSIBLE BICORTICAL SCREWS. THERE WERE 11 FEMALES AND FIVE MALES IN THE PRESENT STUDY WITH THE AVERAGE AGE OF 36 YEARS (RANGE 26¿55 YEARS). THE AVERAGE TIME OF SURGERY BETWEEN THE PRIMARY SURGERY OF INTERLOCKING NAIL FIXATION AND THE PLATE AUGMENTATION WAS 13 MONTHS (RANGE 12¿15 MONTHS). NO NEUROVASCULAR COMPLICATIONS WERE NOTICED AFTER THE SURGICAL PROCEDURE; ONE PATIENT DEVELOPED SURGICAL SITE INFECTION WHICH REQUIRED THE ADDITIONAL PROCEDURE OF DEBRIDEMENT. IN THIS PATIENT WOUND HEALED COMPLETELY IN THREE WEEKS. THIS REPORT IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN LCDCP AND REFERS TO THE SERIOUS INJURY OF 14, (B)(6) FEMALE WHO EXPERIENCED SURGICAL SITE INFECTION AND DEBRIDEMENT. THIS REPORT IS FOR CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535301 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention