BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: TRAUMA

    MDR report key: 10789249 · Received November 4, 2020

    Report

    Report Number
    8030965-2020-08604
    Event Type
    Injury
    Date Received
    November 4, 2020
    Date of Event
    February 28, 2019
    Report Date
    October 9, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREWS: TRAUMA/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LEE S., HAN S., YOO B., KIM J., (2019)OUTCOMES OF LOCKING PLATE FIXATION WITH FIBULAR ALLOGRAFT AUGMENTATION FOR PROXIMAL HUMERAL FRACTURES IN OSTEOPOROTIC PATIENTS COMPARISON WITH LOCKING PLATE FIXATION ALONE,THE BONE JOINT JOURNAL, VOLUME 101-B, PAGES 260¿265 (KOREA, SOUTH) DOI: 10.1302/0301-620X.101B3.BJJ-2018-0802.R1. THIS STUDY AIMS TO COMPARE AND ANALYZE THE CLINICAL AND RADIOLOGICAL OUTCOMES OF USING A LOCKING PLATE IN THE MANAGEMENT OF A DISPLACED PROXIMAL HUMERAL FRACTURE WITH AND WITHOUT AN ASSOCIATED FIBULAR ALLOGRAFT. BETWEEN 2007 AND 2016, 112 CONSECUTIVE PATIENTS WITH A PROXIMAL HUMERAL FRACTURE WERE SURGICALLY TREATED. BETWEEN 2007 AND 2012, 61 PATIENTS UNDERWENT LOCKING PLATE FIXATION ONLY (LP GROUP) 52 PATIENTS (14 MALES, 38 FEMALES) MEAN AGE 73.3 (RANGE 52 TO 89) OF THESE WERE EVALUATED .BETWEEN 2013 AND 2016, 51 PATIENTS UNDERWENT LOCKING PLATE FIXATION WITH AN ASSOCIATED FIBULAR STRUT ALLOGRAFT (FA GROUP) 45 PATIENTS (12 MALES, 33 FEMALES) MEAN AGE 75.6 YEARS (RANGE 55 TO 87) OF THESE WERE EVALUATED. A 3.5 MM PROXIMAL HUMERAL LOCKING PLATE (PHILOS; DEPUY SYNTHES, PAOLI, PENNSYLVANIA) WAS USED IN ALL PATIENTS. MEAN FOLLOW-FOR LP GROUP 14.2 MTHS (12 TO 19 RANGE) WHILE FOR FA GROUP IS 2.6 MTHS (12 TO 17 RANGE). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: FOUR PATIENTS HAD VARUS MALALIGNMENT AND TWO HAD CHANGES IN HHH THAT WERE > 3 MM. ONE PATIENT IN THE FA GROUP DEVELOPED OSTEONECROSIS (FIG. 3). HE HAD MINOR SYMPTOMS THAT RESPONDED TO CONSERVATIVE TREATMENT. THERE WAS FAILURE OF FIXATION IN ONE PATIENT IN THE LP GROUP (FIG. 2). THERE WAS PENETRATION OF A SCREW IN FOUR PATIENTS AND LOOSENING OF A SCREW IN ONE. A SCREW WAS REMOVED IN FOUR AND LEFT IN SITU IN ONE DUE TO HIS GENERAL CONDITION. THERE WAS PENETRATION OF A SCREW IN FOUR PATIENTS AND LOOSENING OF A SCREW IN ONE. ONE SCREW WAS LEFT IN SITU IN ONE DUE TO HIS GENERAL CONDITION. THIS REPORT IS FOR AN UNKNOWN SYNTHES 3.5 MM PROXIMAL HUMERAL LOCKING PLATE. THIS REPORT IS FOR ONE (1) UNK - SCREWS: TRAUMA. THIS IS REPORT 10 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253790 UNK - SCREWS: TRAUMA SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention