BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 8613355 · Received May 15, 2019

    Report

    Report Number
    8030965-2019-63987
    Event Type
    Injury
    Date Received
    May 15, 2019
    Report Date
    April 17, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME, COMMON DEVICE NAME, PROCODE, MFR, LOT #, PART #, UDI #, 510K: THIS REPORT IS FOR UNKNOWN LOCKING SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATED BY MFR, MANUFACTURE DATE: 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. (B)(4). 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: MARESCA, A. ET AL (2017), "WHY A SURGICALLY TREATED HUMERAL SHAFT FRACTURE BECAME A NONUNION: REVIEW OF 11 YEARS IN TWO TRAUMA CENTERS." MUSCULOSKELETAL SURGERY DECEMBER 2017, VOLUME 101, SUPPLEMENT 2, PAGES 105-112 (ITALY) DOI 10.1007/S12306-017-0509-5. THIS RETROSPECTIVE STUDY AIMS TO EVALUATE NONUNION CAUSES OF SURGICALLY TREATED HUMERAL SHAFT FRACTURES IN TWO DIFFERENT TRAUMA CENTERS. FROM 2005 TO 2015, A TOTAL OF 327 HUMERAL SHAFT FRACTURES SURGICALLY TREATED HAVE BEEN EXAMINED. AMONG THESE, 224 (114 MALE 110 FEMALE) WITH AN AVERAGE AGE OF 55 YEARS WERE TREATED AT MAGGIORE HOSPITAL OF BOLOGNA FROM JANUARY 2005 TO DECEMBER 2011. SIXTEEN (16) WERE OPEN FRACTURES. ONE HUNDRED AND SIXTY-FIVE (165) CASES WERE TREATED WITH A 4.5 STRAIGHT PLATE FIXATION,1 CASE WITH A 3.5 STRAIGHT PLATE, 50 CASES WITH AN ANATOMICAL SITE-SPECIFIC PROXIMAL HUMERAL 3.5-MM LCP PLATE. FIFTEEN NONUNION WAS OBSERVED. FROM JANUARY 2012 TO DECEMBER 2015, 103 HUMERAL DIAPHYSIS FRACTURE CASES (40 MALE 63 FEMALE) WITH AN AVERAGE AGE OF 64 YEARS WERE TREATED AT (B)(6) HOSPITALS OF ANCONA. FORTY-TWO (42) CASES WERE TREATED WITH A 4.5 STRAIGHT PLATE, THIRTY-ONE (31) CASES WITH AN ANATOMICAL SITE-SPECIFIC PROXIMAL HUMERAL 3.5-MM LCP PLATE (SYNTHES, PAOLI, PA, USA) 4 NONUNION WERE OBSERVED. THE FOLLOWING COMPLICATIONS WERE REPORTED: AT MAGGIORE HOSPITAL OF BOLOGNA: A CASE OF (B)(6) WITH AN INITIAL OF (B)(6) HAD AN INITIAL TREATMENT USING A 3.5 MM LCP PLATE 6 MONTHS AFTER HAD SCREW BREAKAGE. A SECOND TREATMENT WAS DONE WITH USING A 4.5 PLATE AND BONE GRAFT. THERE WAS A CONSOLIDATION. A CASE OF A (B)(6) WITH AN INITIAL OF (B)(6) HAD AN INITIAL TREATMENT USING A 3.5 MM LCP PLATE, 5 MONTHS AFTER HAD PLATE BREAKAGE. SECOND TREATMENT A 3.5 ANATOMICAL PROXIMAL HUMERAL 3.5 MM LCP PLATE AND GRAFT WAS USED. THERE WAS CONSOLIDATION A CASE OF A (B)(6) WITH AN INITIAL OF (B)(6) HAD AN INITIAL TREATMENT USING A 3.5 MM LCP PLATE, AFTER 6 MONTHS HAD FAILED CONSOLIDATION. A SECOND TREATMENT WAS DONE WITH USING A 4.5 PLATE AND BONE GRAFT. THERE WAS A SUCCESSFUL CONSOLIDATION A CASE OF AN (B)(6) WITH AN INITIAL OF (B)(6) HAD INITIAL TREATMENT USING A 3.5 MM LCP PLATE, 5 MONTHS AFTER HAD PLATE AND SCREW LOOSENING. SECOND TREATMENT WAS DONE USING A 4.5 PLATE AND BONE GRAFT. THERE WAS NO CONSOLIDATION AND AFTER 5 MONTHS A CUTOUT OF THE PROXIMAL SCREWS FOR OSTEOPOROTIC BONE WAS DONE. AT (B)(6) HOSPITAL: A CASE OF AN (B)(6) WITH AN INITIAL OF (B)(6) HAD AN INITIAL TREATMENT USING 3.5 MM LCP PLATE, 8 MONTHS AFTER HAD LOSS OF BONE SUBSTANCE FRAGMENT RESORPTION DUE TO SCREWS BREAKAGE. SECOND TREATMENT WAS DONE USING A 3.5 PHILOS AND BONE GRAFT. THERE WAS A CONSOLIDATION. A CASE OF AN (B)(6) WITH AN INITIAL OF (B)(6) HAD AN INITIAL TREATMENT USING A 3.5 MM LCP PLATE, 12 MONTHS AFTER HAD FRAGMENT RESORPTION DUE TO PLATE BREAKAGE. SECOND TREATMENT WAS DONE USING A 4.5 PLATE AND BONE GRAFT. THERE WAS CONSOLIDATION. A CASE OF A (B)(6) HAD WITH AN INITIAL OF (B)(6) HAD AN INITIAL TREATMENT WITH 3.5 MM LCP PLATE, 11 MONTHS AFTER HAD PLATE BREAKAGE. SECOND TREATMENT WAS DONE USING A 4.5 PLATE AND BONE GRAFT. THERE WAS CONSOLIDATION. A CASE OF AN (B)(6) FEMALE HAD AN ACCIDENTAL FALL WITH A 3.5 LCP PLATE FIXATION, 5 MONTHS AFTER HAD BONE FRAGMENT RESORPTION AND BREAKING HARDWARE. A CASE OF A (B)(6) WITH AN INITIALS OF (B)(6) AT MAGGIORE HOSPITAL WHO HAD A SECOND TREATMENT USING A 4.5 PLATE BONE GRAFT HAD FRAGMENTS FAILURE. NO PLATE COMPRESSION. THIS REPORT IS FOR UNKNOWN SYNTHES LOCKING SCREWS. THIS IS REPORT 4 OF 4 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405742 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention