BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 6082236 · Received November 7, 2016

    Report

    Report Number
    2520274-2016-15246
    Event Type
    Injury
    Date Received
    November 7, 2016
    Date of Event
    June 21, 2007
    Report Date
    October 14, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN LCP OR LCP-DCP / UNKNOWN QUANTITY / UNKNOWN LOT. (OTHER NUMBER): UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS 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 LITERATURE ARTICLE, GARDNER, M., TORO-ARBELAEZ, J., BORAIAH, S., LORICH, D. AND HELFET, D. (2008). SURGICAL TREATMENT AND OUTCOMES OF EXTRA ARTICULAR PROXIMAL TIBIAL NONUNIONS. ARCH ORTHOP TRAUMA SURG, 128, 833-839. THE PURPOSE OF THIS STUDY WAS TO DETERMINE THE LONG-TERM FUNCTIONAL OUTCOMES OF PATIENTS TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF EXTRA ARTICULAR PROXIMAL TIBIAL NONUNIONS. SIXTEEN PATIENTS WITH A PROXIMAL TIBIAL NONUNION WERE TREATED BETWEEN 1992 AND 2005. ALL OF THE PATIENTS MET THE STUDY CRITERIA AND WERE INCLUDED IN THE ANALYSIS. AVERAGE AGE WAS 45 YEARS (RANGE, 25-62 YEARS), AND 11 PATIENTS WERE MALE. ALL PATIENTS UNDERWENT SURGICAL TREATMENT WITH ORIF, DEBRIDEMENT OF THE NONUNION, CORRECTION OF THE DEFORMITY, BONE GRAFTING AND EARLY SUPERVISED ACTIVE ASSISTED MOTION POSTOPERATIVELY. A HUMERAL BLADE PLATE WAS USED IN ONE EARLY CASE, AND FOR THE REMAINING 15 PATIENTS, A LATERAL PLATE (11 LOCKING PLATES (LCP, SYNTHES, (B)(4)) AND 4 STANDARD COMPRESSION PLATES (LC-DCP, SYNTHES) WERE USED. CLINICAL FOLLOW-UP AVERAGED 39 MONTHS (RANGE 10-113 MONTHS) WITH RADIOGRAPHIC REVIEW AND A KNEE SOCIETY QUESTIONNAIRE. RESULTS INCLUDED: SERIOUS INJURY PATIENT 13, A (B)(6) MALE FELL FROM A SCAFFOLD AND SUSTAINED A 41-C2 FRACTURE. HE WAS INITIALLY TREATED WITH SYNTHES LESS INVASIVE STABILIZATION SYSTEM (LISS). HE SMOKED TWO PACKS OF CIGARETTES PER DAY, AND REQUIRED TWO ADDITIONAL REVISION PROCEDURES OVER AN EIGHT MONTH TREATMENT COURSE. HE CONTINUES TO HAVE INTERMITTENT CHRONIC PAIN AND DIFFICULTY AMBULATING. THE AUTHORS DID NOT SPECIFY WHICH DEVICE (LCP OR LCP-DCP) WAS USED FOR THE ADDITIONAL REVISION SURGERIES. SERIOUS INJURY: PATIENT 14, A (B)(6) FEMALE WAS STRUCK BY A CAR AND SUSTAINED A 41-C3 FRACTURE. SHE UNDERWENT SURGICAL TREATMENT WITH BICONDYLAR BUTTRESS PLATING TEN MONTHS PRIOR TO REFERRAL TO THE AUTHORS' INSTITUTION. SHE DID NOT PARTICIPATE IN REHABILITATION AND DEVELOPED A 20 DEGREE ANKLE EQUINUS CONTRACTURE AND KNEE RANGE OF MOTION OF 0-60 DEGREES. HER NONUNION HEALED SEVEN MONTHS FOLLOWING HER REVISION SURGERY, BUT SHE DEVELOPED SEVERE KNEE ARTHROSIS AND WAS REFERRED FOR TOTAL KNEE ARTHROPLASTY. THE AUTHORS DID NOT SPECIFY WHICH DEVICE (LCP OR LCP-DCP) WAS USED FOR TREATMENT. SERIOUS INJURY: ONE PATIENT DEVELOPED AN EARLY INFECTION THAT REQUIRED IRRIGATION AND DEBRIDEMENT; THE PATIENT ULTIMATELY HAD A GOOD FUNCTIONAL OUTCOME. THE AUTHORS DID NOT SPECIFY WHICH DEVICE (LCP OR LCP-DCP) WAS USED FOR TREATMENT. THIS IS REPORT 4 OF 4 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN LCP OR LCP-DCP AND REFERS TO ONE PATIENT WHO DEVELOPED AN EARLY INFECTION THAT REQUIRED IRRIGATION AND DEBRIDEMENT; THE PATIENT ULTIMATELY HAD A GOOD FUNCTIONAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734274 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention