BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4221945 · Received November 3, 2014

    Report

    Report Number
    2520274-2014-14416
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 16, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ROTHENFLUH, E., SCHWEIZER, A., NAGY, L., (2013), OPENING WEDGE OSTEOTOMY FOR DISTAL RADIUS MALUNION: DORSAL OR PALMAR APPROACH?, JOURNAL OF WRIST SURGERY, 2, 49-54. THIS REPORT IS FOR AN UNKNOWN SCREW. (B)(4) A SECONDARY DISLOCATION OF THE DISTAL FRAGMENT OBSERVED 21 DAYS AFTER SURGERY, SO THAT A REVISION SURGERY WAS NECESSARY. 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. 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: ROTHENFLUH, E., SCHWEIZER, A., NAGY, L., (2013), OPENING WEDGE OSTEOTOMY FOR DISTAL RADIUS MALUNION: DORSAL OR PALMAR APPROACH?, JOURNAL OF WRIST SURGERY, 2, 49-54. ALL OSTEOTOMIES OF THE DISTAL RADIUS PERFORMED AT THEIR INSTITUTION FROM APRIL 6, 1999, THROUGH APRIL 08, 2009, WERE COLLECTED (N=65). OUT OF 65 PATIENTS THAT WERE INITIALLY IDENTIFIED ONLY 24 FIT IN THE INCLUSION CRITERIA FOR THE STUDY. THE 24 PATIENTS THAT WERE INCLUDED HAD A COLLES-TYPE DEFORMITY (MALUNION IN EXTENSION AND SHORTENING). OF THESE PATIENTS, ONE PATIENT WAS NOT AVAILABLE FOR THE STUDY AND ANOTHER DECLINED TO PARTICIPATE. THE FINAL EVALUATION WAS BASED UPON 22 PATIENTS: 14 PATIENTS AFTER CORRECTIVE OSTEOTOMY THROUGH A PALMAR APPROACH, USING A FIXED-ANGLE PLATE IN CONJUNCTION WITH A CANCELLOUS BONE GRAFT, AND 8 PATIENTS AFTER OSTEOTOMY FROM DORSAL AND CORRECTION RELYING UPON THE SHAPE OF A STRUCTURAL CORTICOCANCELLOUS GRAFT INSERTED FROM DORSAL. THERE WERE 10 WOMEN AND 12 MEN; THE AVERAGE AGE WAS 45 YEARS (11¿84 YEARS). IN THE DORSAL GROUP A COMPETITOR¿S PLATE AND SCREW WAS USED AND IN THE PALMER GROUP A 2.4MM LOCKING COMPRESSION PLATE (T-PLATE) WAS USED. THE ONLY COMPLICATIONS THAT WERE REPORTED FOR THE PALMER GROUP ARE HARDWARE REMOVAL FOR UNSPECIFIC PAIN OR PLATE PROMINENCE. IN ONE PATIENT A SECONDARY DISLOCATION OF THE DISTAL FRAGMENT WAS OBSERVED 21 DAYS AFTER SURGERY, SO THAT A REVISION SURGERY WAS NECESSARY. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701429 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention