BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE

    MDR report key: 3904873 · Received July 1, 2014

    Report

    Report Number
    2520274-2014-11997
    Event Type
    Injury
    Date Received
    July 1, 2014
    Report Date
    June 11, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE 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. (B)(6). CHIRPAZ-CERBAT, J., RUATTI, S., HOUILLON, C., & IONESCU, S. (2011). DORSALLY DISPLACED DISTAL RADIUS FRACTURES TREATED BY FIXED-ANGLE VOLAR PLATING: GRIP AND PRONOSUPINATION STRENGTH RECOVERY. A PROSPECTIVE STUDY. ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH, 97, 465-470. THIS REPORT IS FOR UNKNOWN FIXED-ANGLE VOLAR PLATES, UNKNOWN PART NUMBER AND UNKNOWN LOT NUMBER. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE ¿DORSALLY DISPLACED DISTAL RADIUS FRACTURES TREATED BY FIXED-ANGLE VOLAR PLATING: GRIP AND PRONOSUPINATION STRENGTH RECOVERY. A PROSPECTIVE STUDY¿ ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH (2011) 97, 465¿470. A SINGLE-CENTER CONTINUOUS NON-RANDOMIZED AND NONCOMPARATIVE PROSPECTIVE STUDY RECRUITED 25 PATIENTS (14 MALE, 11 FEMALE) PRESENTING WITH DISTAL RADIUS FRACTURE WITH DORSAL DISPLACEMENT, MANAGED BY FIXED-ANGLE PALMAR PLATE, BETWEEN JANUARY 2007 AND MAY 2008. IN 12 CASES A COMPETITOR'S PLATE WAS USED, IN 10 CASES THE DRP OF SYNTHES WAS USED, AND IN 4 CASES ANOTHER COMPETITOR'S PLATE WAS USED. MEAN AGE WAS 47.5 YEARS (RANGE: 17¿72 YEARS); ONLY ONE PATIENT WAS OVER 65 YEARS OF AGE. THE STUDY ASSESSED RECOVERY OF GRIP, PRONATION AND SUPINATION STRENGTH FOLLOWING SUCH INTERNAL FIXATION. ALL SURGERY WAS PERFORMED UNDER PNEUMATIC TOURNIQUET AND VISUAL CONTROL, USING A CLASSIC HENRY APPROACH. PARTICULAR ATTENTION WAS PAID TO THE PRONATOR QUADRATUS MUSCLE. THE SUTURE AT END OF SURGERY WAS JUDGED SOLID IN SEVEN CASES, WEAK IN SEVEN AND WITHOUT FUNCTIONAL VALUE OR IMPOSSIBLE IN 12; IN THESE 12 CASES, THE MUSCLE BODY WAS RETRACTED AND THE APONEUROSIS WAS NOT SOLID ENOUGH FOR SUTURE. CLINICAL FUNCTIONAL ASSESSMENT, AT 20 DAYS, 45 DAYS, 3 MONTHS, 6 MONTHS AND LAST FOLLOW-UP, CONCERNED ROM AND GRIP AND PRONOSUPINATION STRENGTH RECOVERY AS COMPARED TO THE NON-OPERATED SIDE. MEASUREMENTS WERE TAKEN USING PORTABLE APPARATUSES. AT A MEAN 14 MONTHS FOLLOW-UP, GRIP STRENGTH WAS 91% THAT OF THE HEALTHY SIDE. PRONATION AND SUPINATION STRENGTHS WERE EQUIVALENT, AT RESPECTIVELY 88% AND 85% OF HEALTHY-SIDE VALUES. COMPLICATIONS INCLUDED; THREE MALUNIONS RELATED TO ONE REDUCTION DEFECT, AND TWO CASES OF SECONDARY CORRECTION LOSS DUE TO OVER-PROXIMAL PLATE POSITIONING; FOUR POST-TRAUMATIC CARPAL TUNNEL SYNDROMES, REQUIRING SECONDARY MEDIAL NERVE RELEASE IN THREE CASES, WITH REMOVAL OF MATERIAL BETWEEN MONTHS 4 AND 9; AND TWO SYNDROMES SUGGESTIVE OF MILD REGRESSIVE REFLEX SYMPATHETIC DYSTROPHY. THE ARTICLE DOES NOT STATE WHICH PLATES THE VARIOUS COMPLAINTS WERE AGAINST. THERE WAS A MODERATE CORRELATION BETWEEN MALUNION AND POOR RECOVERY OF GRIP AND PRONATION STRENGTHS AND A WEAK CORRELATION BETWEEN MALUNION AND POOR RECOVERY OF SUPINATION STRENGTH. FRACTURE TYPE (EXTRA- OR INTRA-ARTICULAR) ON THE SOFCOT CLASSIFICATION DID NOT CORRELATE SIGNIFICANTLY WITH RECOVERY OF GRIP OR SUPINATION STRENGTH. DISTAL RADIOULNAR JOINT LESION DID NOT CORRELATE SIGNIFICANTLY WITH RECOVERY OF GRIP. ANALYSIS OF THE RECOVERY OF GRIP STRENGTH AND ESPECIALLY OF PRONOSUPINATION STRENGTH FOUND NO HARMFUL EFFECT OF FIXED ANGLE PALMAR PLATE OSTEOSYNTHESIS, DESPITE IMPACT ON THE PRONATOR QUADRATUS MUSCLE. IN THE ABSENCE OF MALUNION OR JOINT STIFFNESS, THIS TECHNIQUE ALLOWS RECOVERY OF GRIP AND PRONOSUPINATION STRENGTH. THIS REPORT IS AGAINST AN UNKNOWN DRP 2.4 PLATE FOR CARPEL TUNNEL SYNDROME. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384652 PLATE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention