BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5419413 · Received February 9, 2016

    Report

    Report Number
    2520274-2016-10927
    Event Type
    Injury
    Date Received
    February 9, 2016
    Report Date
    January 27, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SAUERBIER, M., KLUGE, S., BICKERT, B., AND GERMANN, G. (2000) SUBJECTIVE AND OBJECTIVE OUTCOMES AFTER TOTAL WRIST ARTHRODESIS IN PATIENTS WITH RADIOCARPAL ARTHROSIS OR KIENBOCK'S DISEASE. CHIR MAIN, VOLUME 19: 223-231. THIS REPORT IS FOR UNKNOWN - AO-WRIST ARTHRODESIS PLATE/UNKNOWN QUANTITY/UNKNOWN LOT. (B)(4) CARPAL TUNNEL RELEASE, TENOLYSIS, POSTOPERATIVE ULNOCARPAL ABUTMENT, AND REDUCTION OF POSTOPERATIVE QUALITY OF LIFE WITH IRNPAIRED PERSONAL HYGIENE AND FUNCTIONAL DEFICITS. 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 SAUERBIER, M., KLUGE, S., BICKERT, B., AND GERMANN, G. (2000) SUBJECTIVE AND OBJECTIVE OUTCOMES AFTER TOTAL WRIST ARTHRODESIS IN PATIENTS WITH RADIOCARPAL ARTHROSIS OR KIENBOCK'S DISEASE. CHIR MAIN, VOLUME 19: 223-231. THE PURPOSE OF THIS ARTICLE IS TO EVALUATE THE FUNCTIONAL OUTCOME, THE PATIENT'S PAIN PERCEPTION, QUALITY OF LIFE WITH THE DISABILITIES OF THE ARM, SHOULDER, AND HAND (DASH) QUESTIONNAIRE AND THE COMPARISON OF THE DASH DATA ('SUBJECTIVE') WITH DATA ('OBJECTIVE') FROM TWO ESTABLISHED WRIST SCORES. A RETROSPECTIVE STUDY WAS DONE BETWEEN JANUARY 1986 TO OCTOBER 1996, WHERE SIXTY (60) PATIENTS WHO UNDERWENT WRIST ARTHRODESIS FOR POST-TRAUMATIC ARTHROSIS OR KIENBOCK'S DISEASE. THERE WERE FORTY-NINE (49) MEN AND ELEVEN (11) WOMEN. THE AGE OF THE PATIENTS RANGED FROM 19 TO 71 YEARS (MEAN, 48 YEARS). THE MEAN FOLLOW-UP WAS 37 MONTHS (RANGE, 15 TO 120 MONTHS). THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN - AO-WRIST ARTHRODESIS PLATE AND REFERS TO EIGHTY (80%) PERCENT OF UNKNOWN PATIENTS COMPLAINED ABOUT REDUCTION OF POSTOPERATIVE QUALITY OF LIFE WITH IMPAIRED PERSONAL HYGIENE AND FUNCTIONAL DEFICITS, TWENTY-ONE (21) UNKNOWN PATIENTS WHO REQUIRED FURTHER SURGERY SUCH AS CARPAL TUNNEL RELEASE, TENOLYSIS AND/OR HARDWARE REMOVE, FIVE (5) UNKNOWN PATIENTS WHO HAD NON UNION AND HAD TO BE REOPERATED ON, ONE (1) UNKNOWN PATIENT WHO HAD POSTOPERATIVE ULNOCARPAL ABUTMENT, AND NINE (9) UNKNOWN PATIENTS WHO COMPLAINED FROM DONOR SITE MORBIDITY AT THE ILIAC CREST. THE PROBLEMS WERE DUE TO PERSISTING IRRITATIONS OF THE LATERAL FEMORAL CUTANEOUS NERVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83262 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention