BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 8258162 · Received January 17, 2019

    Report

    Report Number
    8030965-2019-60007
    Event Type
    Injury
    Date Received
    January 17, 2019
    Report Date
    December 27, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN SCREWS. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR UNKNOWN SCREWS. PMA/510(K) NUMBER IS NOT AVAILABLE. (B)(4). PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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: KATTHAGEN, J.C. ET AL (2012), ARTHROSCOPIC IMPLANT REMOVAL AFTER FIXED-ANGLE PLATE OSTEOSYNTHESIS OF THE PROXIMAL HUMERUS TECHNIQUE AND INITIAL RESULTS IN COMPARISON TO OPEN IMPLANT REMOVAL, THE TRAUMA SURGEON (DER UNFALLCHIRURG) VOL. 115 ISSUE 1, PAGES 47-58 (GERMANY). THE OBJECTIVE OF THIS STUDY WAS TO DETERMINE WHETHER COMPARABLE RESULTS CAN BE ACHIEVED AS WITH OPEN ME; WHETHER THE DESIRED FUNCTIONAL RESULT CAN BE ACHIEVED FASTER; HOW OFTEN INTRAARTICULAR CONCOMITANT PATHOLOGIES EXIST, AND CAPSULOTOMIES BECOME NECESSARY. FROM JULY 2008 TO DECEMBER 2009, 29 CONSECUTIVELY TREATED PATIENTS (17 WOMEN, 12 MEN) WITH MEDIAN AGE OF 56 (30-82) YEARS ON 30 UPPER LIMBS HAD A COMPLETE IMPLANT REMOVAL AND ARTHROLYSIS AFTER PLATE OSTEOSYNTHESIS OF PROXIMAL HUMERAL FRACTURE: 20 PATIENTS (13 WOMEN, 7 MEN) AT A MEDIAN AGE OF 64 (30-82) YEARS HAD AN ARTHROSCOPIC ME ON 21 UPPER EXTREMITIES (12 LEFT, 9 RIGHT); 9 PATIENTS (4 WOMEN, 5 MEN) AT A MEDIAN AGE OF 53 (34-76) YEARS HAD AN OPEN ME, 5 ON THE RIGHT AND 4 ON THE LEFT SIDE. IN THE ARTHROSCOPIC ME PATIENT POPULATION, 17 PATIENTS (10 WOMEN, 7 MEN) ON 18 UPPER EXTREMITIES HAD THE FRACTURE TREATED USING ANGLE-STABLE PLATE OSTEOSYNTHESIS (PHILOS, SYNTHES®, FREIBURG, DEUTSCHLAND). IN THE 3 PATIENTS, THE ORIGINAL NUMBER OF SEGMENTS WAS NOT KNOWN; FIXATION OF THE FRACTURE WAS PERFORMED WITH DIFFERENT ANGLE-STABLE IMPLANTS. IN THE OPEN ME PATIENT POPULATION, 7 PATIENTS (4 WOMEN, 3 MEN) AT 7 UPPER EXTREMITIES HAD THE PRIMARY FRACTURE TREATMENT USING ANGLE-STABLE PLATE OSTEOSYNTHESIS (PHILOS, SYNTHES® FREIBURG, DEUTSCHLAND). IN THE 2 PATIENTS, THE ORIGINAL NUMBER OF SEGMENTS WAS NOT KNOWN, AND FIXATION OF THE FRACTURE WAS PERFORMED WITH DIFFERENT ANGLE-STABLE IMPLANTS. CONSTANT MURLEY SCORE (CMS) AND SIMPLE SHOULDER TEST (SST) WERE DETERMINED. THE CLINICAL FOLLOW-UP OF THE PATIENTS WITH ARTHROSCOPIC ME WAS ON AVERAGE 7.6 (3¿16) MONTHS AFTER ME, THE CLINICAL FOLLOW-UP OF THE PATIENTS WITH OPEN ME WAS ON AVERAGE 10.8 (3-17) MONTHS AFTER ME. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: (B)(6) MALE HAD SCREW PERFORATION IN ME ON PATIENT REQUEST 2 YEARS AFTER ANGLE-STABLE PLATE OSTEOSYNTHESIS. FIVE PATIENTS HAD REVISION SURGERY 3-5 WEEKS AFTER PRIMARY CARE: 2 TIMES DISLOCATION REOSTEOSYNTHESIS; 2 TIMES SCREW SHORTENING; 1 SCREW AND HEMATOMA REMOVAL. THE INDICATION FOR ME WAS MAINLY DUE TO RESTRICTION OF MOVEMENT AND MATERIAL-RELATED COMPLICATIONS SUCH AS SCREW PERFORATION AND PLATE IMPINGEMENT WITH TOO CRANIAL PLATE POSITION AS SEEN IN TAB. 1: 10 HAD IMPLANT REMOVAL DUE TO MOVEMENT RESTRICTION WITHOUT MATERIAL DISLOCATION. 6 HAD IMPLANT REMOVAL DUE TO MOVEMENT RESTRICTION IN SCREW PROTRUSION. 3 PATIENTS REQUEST OF IMPLANT REMOVAL IN FULL RANGE OF MOVEMENT. 2 HAD IMPLANT REMOVAL DUE TO MOVEMENT RESTRICTION DUE TO CRANIAL PLATE AND MATERIAL. IN THE PATIENT POPULATION EXCLUSIVELY TREATED ARTHROSCOPICALLY, ALL PATIENTS HAD SUBACROMIAL THERAPY: 20 OF THE 21 ME HAD SUBACROMIAL ARTHROLYSIS, 6 PATIENTS HAD SUBACROMIAL DECOMPRESSION AND BURSECTOMY. IN 17 OUT OF 21 CASES, IN ADDITION TO THE SUBACROMIAL THERAPY, THE TREATMENT OF AT LEAST ONE INTRAARTICULAR CONCOMITANT PATHOLOGY BECAME NECESSARY AS SEEN IN TAB. 2: IN 13 ME THERE WAS INTRAARTICULAR ARTHROLYSIS TRANSECTION OF THE CORACOHUMERAL LIGAMENT OR 360 ° CAPSULOTOMY. IN 12 OUT OF 21 CASES, CONCOMITANT INJURIES OF THE ROTATOR CUFF, BICEPS TENDON AND ANCHOR, ARTICULAR CARTILAGE OR TUBEROSITY WERE ADDRESSED. IN THE 6 PATIENTS, WHO HAD AN ARTHROSCOPY OF THE AFFECTED SHOULDER BEFORE OPEN ME, AN INTRAARTICULAR CONCOMITANT PATHOLOGY WAS ALSO TREATED AS SEEN IN TAB. 2: INTRAARTICULAR ARTHROLYSIS AND TRANSECTION OF THE CORACOHUMERAL LIGAMENT WERE PERFORMED IN 4 PATIENTS. IN 5 OUT OF 6 CASES, CONCOMITANT INJURIES OF BICEPS TENDON ANCHORS, ARTICULAR CARTILAGE OR TUBEROSITY WERE ADDRESSED. IN THE OPEN-OPERATED PATIENTS, 3 HAD REVISION SURGERY 3-6 WEEKS AFTER PRIMARY CARE: 1 DISLOCATION REOSTEOSYNTHESIS. 1 REMOVAL OF INTRAARTICULAR FRAGMENTS AND REFIXATION OF THE GREATER TUBEROSITY. 1 ARTHROSCOPIC ARTHROLYSIS AND ROTATOR CUFF REFIXATION. IN 3 ADDITIONAL PATIENTS AN ARTHROSCOPIC ME WAS INITIALLY SCHEDULED AND HAD TO BE CHANGED SECONDARILY TO OPEN PROCEDURE: 2 PATIENTS HAD OSSIFIED PLATE. 1 PATIENT HAD COLD-WELDED SCREWS. THIS REPORT IS FOR AN UNKNOWN LOCKING SCREWS. THIS IS REPORT 4 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49073 SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention