BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

    MDR report key: 5608949 · Received April 26, 2016

    Report

    Report Number
    2520274-2016-12258
    Event Type
    Injury
    Date Received
    April 26, 2016
    Report Date
    April 20, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RAHMAN, O., KHAN, M.Q., RASHEED, H., AND AHMAD, S. (2012). TREATMENT OF UNSTABLE INTRAARTICULAR FRACTURE OF THE DISTAL RADIUS: POP CASTING WITH EXTERNAL FIXATION. J PAK MED ASSOC. 62(4), 358-362. THIS REPORT IS FOR AN UNKNOWN EXTERNAL FIXATOR/UNKNOWN LOT/QUANTITY OF 4. (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(4). 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. 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

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, RAHMAN, O., KHAN, M.Q., RASHEED, H., AND AHMAD, S. (2012). TREATMENT OF UNSTABLE INTRAARTICULAR FRACTURE OF THE DISTAL RADIUS: POP CASTING WITH EXTERNAL FIXATION. J PAK MED ASSOC. 62(4), 358-362. PAKISTAN ARTICLE. THE PURPOSE OF THIS STUDY WAS TO COMPARE RADIOLOGICAL AND FUNCTIONAL OUTCOME OF EXTERNAL FIXATION AND DISTRACTION WITH CONSERVATIVE PLASTER OF PARIS (POP) CAST FOR UNSTABLE INTRA-ARTICULAR FRACTURES OF THE DISTAL RADIUS. A RANDOMISED CONTROL TRIAL (CONCURRENT PARALLEL TYPE) WAS CONDUCTED ON 60 PATIENTS WITH UNSTABLE INTRA-ARTICULAR FRACTURE OF THE DISTAL RADIUS WHO REPORTED TO EITHER THE EMERGENCY OR OUTPATIENT FACILITIES OF THE ORTHOPAEDIC SURGERY DEPARTMENT OF BENAZIR BHUTTO HOSPITAL, RAWALPINDI, BETWEEN MARCH AND AUGUST 2007. PATIENTS MEETING THE CRITERIA WERE DIVIDED BY LOTTERY METHOD, WITH ODD NUMBERS TO GROUP A AND EVEN NUMBERS TO GROUP B. THE AGE OF PATIENTS RANGED BETWEEN 32 AND 58 YEARS, AVERAGE 42.7 ±7. MALE TO FEMALE RATIO WAS 38 TO 22 I.E. 1.7:1. GROUP A PATIENTS WERE TREATED WITH ABOVE-ELBOW POP CAST AFTER REDUCTION OF FRACTURE. GROUP B PATIENTS WERE TREATED BY EXTERNAL FIXATION WITH DISTRACTION APPLIED WITHIN 1 TO 2 DAYS OF PRESENTATION. EXTERNAL FIXATOR (AO TYPE) WAS APPLIED UNDER GENERAL ANAESTHESIA IN THE OPERATION THEATRE. THE FIXATOR CONSISTED OF 3.5 MM SCHANZ PINS AND ATTACHMENT CLAMPS AND RODS. LOSS OF REDUCED POSITION OCCURRED IN 2 CASES IN GROUP B. REFLEX SYMPATHETIC DYSTROPHY DEVELOPED IN 2 CASES OF GROUP B. THIS REPORT IS FOR AN UNKNOWN EXTERNAL FIXATOR. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263270 APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention