BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALLUFIX PLATE, UNKNOWN

    MDR report key: 7570936 · Received June 5, 2018

    Report

    Report Number
    9615741-2018-00080
    Event Type
    Injury
    Date Received
    June 5, 2018
    Report Date
    April 30, 2018
    Manufacturer
    NEWDEAL SAS
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTAL HYGIENIST

    Narratives

    Additional Manufacturer Narrative · 0

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION: AS PRODUCTS ARE NOT RETURNED, NO FAILURE ANALYSIS WAS PERFORMED. AS NO PRODUCT ID AND NO MANUFACTURING LOT NUMBER WAS PROVIDED, NO DHR, DESIGN SPECIFICATION OR DESIGN CHANGE RECORD WILL BE PERFORMED. A REVIEW OF THE CURRENT ¿INSTRUCTION FOR USE ND 01031 (NON-STERILE) AND ND 01831(STERILE)¿ WAS PERFORMED. AS WE CAN SEE IN PARAGRAPH ¿PRECAUTIONS FOR USE¿, THAT ¿BONE NON-UNION OR DELAYED UNION¿, ARE MENTIONED AS FREQUENT ADVERSE EVENTS THAT COULD LEAD INTO RE-OPERATION, REVISION OR REMOVAL SURGERY, ARTHRODESIS OF THE INVOLVED JOINT, AND /OR AMPUTATION OF THE LIMB. IN CONCLUSION: FREQUENT ADVERSE EVENTS ARE MENTIONED IN IFU. AS DHR REVIEW AND FAILURE ANALYSIS COULD NOT BE PERFORMED, ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE JOURNAL OF FOOT AND ANKLE SURGERY (2012) PUBLISHED: "ARTHRODESIS OF THE FIRST METATARSOPHALANGEAL JOINT: A RETROSPECTIVE ANALYSIS OF PLATE VERSUS SCREW FIXATION." THE PURPOSE OF THIS STUDY WAS TO IDENTIFY THE BEST FIXATION CONSTRUCT IN REGARD TO FUSION RATES AND RADIOLOGIC NONUNION. SEVENTY-TWO PROCEDURES WERE PERFORMED IN 69 PATIENTS: 48 FEMALES AND 21 MALES. THEIR MEDIAN AGE WAS 62 (RANGE 36 TO 84). YEARS. THESE PATIENTS HAD UNDERGONE SURGERY ON 41 RIGHT AND 31 LEFT FEET; 3 PATIENTS HAD RECEIVED BILATERAL PROCEDURES. BECAUSE DIFFERENT FIXATION TECHNIQUES WERE USED, THESE PATIENTS WERE DIVIDED INTO 4 SUBGROUPS: (1) SINGLE 2.7-MM CANNULATED, SELF-TAPPING LAG SCREW FIXATION (BOLD SCREW, INTEGRA LIFE SCIENCES, (B)(4); N ¼ 24), (2) CROSSED 2.7-MM, CANNULATED, SELF-TAPPING LAG SCREW FIXATION (N ¼ 21), (3) PRECONTOURED TITANIUM ALLOY, LOW-PROFILE, NONLOCKING PLATE (HALLUFIX S-PLATE SYSTEM, INTEGRA LIFE SCIENCES) FIXATION (N ¼ 13), AND (4) PRECONTOURED, TITANIUM ALLOY, LOW-PROFILE, NONLOCKING PLATE (HALLUFIX S-PLATE SYSTEM, INTEGRA LIFE SCIENCES) COMBINED WITH PLANTAR, 2.7-MM, CANNULATED, SELF-TAPPING LAG SCREW FIXATION (N ¼ 14). THE PLATES WERE FIXED USING THE STANDARD 2.7-MM SNAP OFF SCREWS SUPPLIED WITH THE PLATE. ARTHRODESIS OF MTPJ-1 USING A LOW-CONTOURED DORSAL PLATE ALONE WAS PERFORMED IN 10 FEMALE AND 3 MALE PATIENTS. THEY UNDERWENT SURGERY ON 6 RIGHT AND 7 LEFT FEET. THEY HAD A MEDIAN AGE OF 74 (RANGE 36 TO 83) YEARS. THE 14 PATIENTS UNDERGOING ARTHRODESIS FIXED WITH A LOW-CONTOURED DORSAL PLATE AUGMENTED WITH PLANTAR SCREW FIXATION HAD A MEDIAN AGE OF 66 (RANGE 37 TO 80) YEARS; 11 WERE FEMALE AND 3 MALE. THEY UNDERWENT SURGERY ON 8 RIGHT AND 6 LEFT FEET. THE MTPJ-1 ARTHRODESES PERFORMED WITH A LOW-CONTOURED DORSAL PLATE ALONE HAD A FUSION RATE OF 100%, AND THOSE PERFORMED USING A LOW-CONTOURED DORSAL PLATE AUGMENTED WITH PLANTAR SCREW FIXATION HAD A FUSION RATE OF 93%, WITH 13 OF 14 FUSED. EVENTS: ONE PATIENT PRESENTED WITH NONUNION WITH PLATE PLUS SCREW. ELEVEN PATIENTS HAD DELAYED FUSION IN THE 6 WEEKS FOLLOW-UP: 4 DELAYED FUSIONS WITH PLATE AND 7 DELAYED FUSIONS WITH PLATE AND SCREW RESULTS: THE STATISTICAL ANALYSIS OF THE 4 DIFFERENT SUBGROUPS REGARDING FUSION AT 6 WEEKS AND 3 MONTHS AFTER SURGERY SHOWED NO STATISTICALLY SIGNIFICANT DIFFERENCES. AN ANALYSIS OF THE NONUNIONS SHOWED THAT PLATE FIXATION ALONE RESULTED IN A SIGNIFICANTLY LOWER RATE OF NONUNION THAN DID SINGLE SCREW FIXATION (P ¼ .038). WE FOUND NO SIGNIFICANT DIFFERENCE IN THE RESULTS FOR THE OTHER FIXATION TECHNIQUES REGARDING THE RATE OF NONUNION. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO THE AUTHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412914 HALLUFIX PLATE, UNKNOWN HALLU-FIX HTW NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other