BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 8589098 · Received May 7, 2019

    Report

    Report Number
    8030965-2019-63622
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    September 26, 2014
    Report Date
    April 9, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN LOCKING COMPRESSION PLATE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: OH, C.W., BAEK, S.G., KIM, J-W., KIM, J.W. (2015), TIBIAL LENGTHENING WITH A SUBMUSCULAR PLATE IN ADOLESCENTS, JOURNAL OF ORTHOPAEDIC SCIENCE, VOL. 20 (ISSUE 1), PAGES 101-109 (KOREA, SOUTH). THE AIM OF THIS RETROSPECTIVE STUDY IS TO DETERMINE WHETHER TIBIAL LENGTHENING WITH THE AID OF AN EXTERNAL FIXATOR AND PLATE IN ADOLESCENTS PROVIDES LENGTH RESTORATION AND COMPLICATION RATES COMPARABLE TO THE HISTORICAL RESULTS OF OTHER TECHNIQUES. BETWEEN 2006 TO 2011, A TOTAL OF 16 PATIENTS, 20 LEGS, (8 BOYS AND 8 GIRLS) WERE INCLUDED IN THE STUDY. DISTRACTION OSTEOGENESIS WAS PERFORMED USING AN EXTERNAL FIXATOR AND SUBMUSCULAR LOCKING PLATE FIXATION. A 5.0-MM LOCKING COMPRESSION PLATE (LCP; SYNTHES, OBERDORF, SWITZERLAND) WAS USED AS THE INTERNAL FIXATOR, SUBDIVIDED AS FOLLOWS: A PRECONTOURED LCP-PROXIMAL LATERAL TIBIA (PLT) IN 14 CASES, A METAPHYSEAL LCP IN 3 CASES, AND A STANDARD NARROW LCP IN 3 CASES. THE MEAN FOLLOW-UP WAS 39 MONTHS (RANGE 25¿83 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A (B)(6) YEAR-OLD BOY HAD A LEG LENGTH DISCREPANCY OF 30 MM DUE TO SEQUELAE OF LEFT CLUB FOOT. AFTER SCREWS WERE PLACED INTO THE DISTAL HOLES OF THE PERCUTANEOUS PLATE FOLLOWED BY EXTERNAL FIXATOR REMOVAL, IT WAS CORRECTED. 2 FEMALE PATIENTS DEVELOPED A TRANSIENT PERONEAL NERVE PALSY AFTER INDEX LENGTHENING BUT NOT DURING THE DISTRACTION PERIOD. WITH THE AID OF PHYSICAL THERAPY, PALSIES COMPLETELY SUBSIDED 2 AND 3 MONTHS AFTER PHYSICAL THERAPY, RESPECTIVELY. 1 FEMALE PATIENT HAD PLATE BREAKAGE WHICH OCCURRED AFTER A FALL DURING SPORTS AT 4 MONTHS AFTER EXTERNAL FIXATOR REMOVAL, WHICH WAS PRESUMED THAT WEAK FIXATION STABILITY CONTRIBUTED TO THIS FAILURE. 1 MALE PATIENT HAD ANKLE JOINT STIFFNESS RESULTING IN LIMITED COMPLIANCE WHILE WALKING DURING THE DISTRACTION PERIOD. IMPROVEMENT IN THIS CASE REQUIRED VIGOROUS PHYSICAL THERAPY. THE MEAN AMOUNT OF LENGTHENING ACHIEVED BY THE 20 LEGS WAS 4.1 CM (RANGE 3.0¿5.0 CM), WHICH WAS 12.7 % OF PREOPERATIVE BONE LENGTH (RANGE 9.1¿15.8 %). MEAN DURATION OF EXTERNAL FIXATION WAS 60.3 DAYS (RANGE 45¿74 DAYS). MEAN EXTERNAL FIXATION AND HEALING INDICES WERE 14.8 DAYS/CM (RANGE 13.2¿22.5 DAYS/CM) AND 49.1 DAYS/CM (RANGE 37¿59.3 DAYS/CM), RESPECTIVELY. 3 CASES OF TRANSIENT ANGULAR DEFORMITY DURING DISTRACTION: 2 CASES OF VALGUS DEFORMITY AND 1 ANTERIOR ANGULATION (LIFTING OF THE PLATE FROM BONE AT ITS DISTAL PORTION), WHICH WAS PRESUMED THAT ECCENTRIC LENGTHENING FORCES WERE THE PROBABLE CAUSE. 4 CASES OF FIBULAR MIGRATION OF <5 MM, IS ASYMPTOMATIC, AND DID NOT REQUIRE SURGICAL TREATMENT. 9 CASES OF SUPERFICIAL PIN TRACK INFECTIONS WHICH WERE RESOLVED WITH ORAL ANTIBIOTICS AND FREQUENT PIN TRACK CLEANSING. 1 CASE OF CLAMP LOOSENING. 6 CASES OF DISTAL TIBIO-FIBULAR SCREW BREAKAGE, WHICH DEVELOPED DURING THE CONSOLIDATION PERIOD, THAT IS, NOT DURING THE DISTRACTION PERIOD, SUGGESTING THAT WEIGHT-BEARING AND ACTIVE ANKLE JOINT MOTION CONTRIBUTED. THIS REPORT CAPTURES THE REPORTED ADVERSE EVENT OF A FEMALE PATIENT WHO HAD PLATE BREAKAGE DUE TO A FALL DURING SPORTS AT 4 MONTHS AFTER EXTERNAL FIXATOR REMOVAL, WHICH WAS PRESUMED THAT WEAK FIXATION STABILITY CONTRIBUTED TO THIS FAILURE. THIS REPORT IS FOR AN UNKNOWN LOCKING COMPRESSION PLATE. THIS IS REPORT 3 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381360 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1