BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4593349 · Received March 12, 2015

    Report

    Report Number
    2520274-2015-11436
    Event Type
    Injury
    Date Received
    March 12, 2015
    Report Date
    February 25, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. BRAND, J ET AL. (2010) ACCURACY OF HIGH TIBIAL OSTEOTOMY: COMPARISON BETWEEN OPEN- AND CLOSED-WEDGE TECHNIQUE, KNEE SURG SPORTS TRAUMATOL ARTHROSC, 18, PP: 1328¿1333. THIS REPORT IS FOR AN UNKNOWN TOMOFIX SYSTEM. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICES WERE RETURNED AND NO LOT NUMBERS OR PART NUMBERS WERE PROVIDED. 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 THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE ¿ACCURACY OF HIGH TIBIAL OSTEOTOMY: COMPARISON BETWEEN OPEN- AND CLOSED-WEDGE TECHNIQUE.¿ BRAND, J ET AL. (2010). A RETROSPECTIVE STUDY WAS PERFORMED BETWEEN 2001 TO 2005 ON 61 PATIENTS, 42 MALE AND 19 FEMALE RANGING FROM 18 TO 74 YEARS OF AGE. THE STUDY INCLUDED 31 PATIENTS WHO HAD PRIMARY AND 30 PATIENTS WHO HAD POST-TRAUMATIC OSTEOARTHRITIS. FIFTY TWO PATIENTS HAD ALREADY UNDERGONE ONE OR MORE PREVIOUS SURGERY. THE AIM OF THE STUDY WAS TO ANALYZE THE ACCURACY OF HIGH TIBIAL OSTEOTOMY (HTO) COMPARED TO THE PREOPERATIVE PLANNING WITH A SPECIAL PLANNING SOFTWARE. THE HYPOTHESIS WAS THAT HTO WITH AN OPEN-WEDGE OSTEOTOMY (OWO) TECHNIQUE WITH FIXED-ANGLE IMPLANTS IS MORE ACCURATE THAN THE CLOSED-WEDGE OSTEOTOMY (CWO) TECHNIQUE. BETWEEN 2001 AND 2003, 26 PATIENTS WERE TREATED WITH CLOSED-WEDGE HTO AND FROM 2004 TO 2005; 35 PATIENTS RECEIVED OPEN-WEDGE HTO. THE OSTEOTOMY GAP WAS CONTINUOUSLY OPENED AND INTERNAL FIXATION WAS PERFORMED USING FIXED-ANGLE PLATES (TOMOFIX OR LOCKING COMPRESSION PLATE, SYNTHES, (B)(4)). PATIENT AGE, NUMBER OF PREVIOUS SURGERIES AND NUMBER OF CORRECTIONS HAD NO SIGNIFICANT INFLUENCE ON THE ACCURACY OF HTO. CONVERSION TO KNEE ARTHROPLASTY WAS NECESSARY 51 ± 13 MONTHS POSTOPERATIVELY IN THREE PATIENTS (12%) AFTER CWO AND IN ONE PATIENT (3%) AFTER OWO. NO PATIENT DEVELOPED A NON-UNION OR DEEP INFECTION. TWO WOUND INFECTIONS REQUIRING REVISION SURGERY OCCURRED IN BOTH GROUPS. IN THE CWO GROUP, ONE PERSISTENT PERONEAL NERVE INJURY WAS NOTED. THE NUMBER OF COMPLICATIONS WAS NOT SIGNIFICANTLY DIFFERENT BETWEEN CWO AND OWO. IN PATIENTS WITH CONGENITAL VARUS DEFORMITY, THE ACCURACY OF THE CORRECTION WAS SIGNIFICANTLY HIGHER THAN IN PATIENTS WITH POST-TRAUMATIC DEFORMITY. THE AUTHORS RECOMMEND OPEN-WEDGE TECHNIQUE IN COMBINATION WITH FIXED-ANGLE PLATES FOR HIGH TIBIAL OSTEOTOMY. THIS REPORT IS FOR AN UNKNOWN TOMOFIX SYSTEM. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171963 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention