BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PHILOS PLATE/SCREWS

    MDR report key: 11978477 · Received June 10, 2021

    Report

    Report Number
    8030965-2021-04796
    Event Type
    Injury
    Date Received
    June 10, 2021
    Report Date
    May 19, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS FOR AN UNK - CONSTRUCTS: PHILOS PLATE/SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI 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 AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE PRODUCT WAS NOT RETURNED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SUN Q, ET AL. (2020), PLATE FIXATION VERSUS ARTHROSCOPIC-ASSISTED PLATE FIXATION FOR ISOLATED MEDIUM-SIZED FRACTURES OF THE GREATER TUBEROSITY: A RETROSPECTIVE STUDY, ORTHOPEDIC SURGERY, VOLUME 12, NUMBER 5, PAGES 1456-1463, (CHINA). THE PRESENT STUDY AIMED: (I) TO EVALUATE THE EFFECTIVENESS OF ARTHROSCOPIC-ASSISTED PLATE FIXATION (ASPF) IN PATIENTS WITH DISPLACED ISOLATED MEDIUM-SIZED FRACTURES OF THE GREATER TUBEROSITY; (II) TO COMPARE THE FUNCTIONAL OUTCOMES OF ASPF VERSUS OPEN REDUCTION AND INTERNAL PLATE FIXATION (ORIF); (III) TO ASSESS THE RATE OF COMPLICATIONS BETWEEN ASPF VERSUS ORIF IN THE TREATMENT OF DISPLACED ISOLATED MEDIUM-SIZED FRACTURES OF THE GREATER TUBEROSITY. FROM JULY 2013 TO OCTOBER 2017, 46 PATIENTS WITH DISPLACED ISOLATED MEDIUM-SIZED FRACTURES OF THE GREATER TUBEROSITY WHO UNDERWENT ARTHROSCOPIC-ASSISTED PLATE FIXATION (ASPF GROUP) OR OPEN REDUCTION AND INTERNAL PLATE FIXATION (ORIF GROUP). THERE WERE 19 PATIENTS IN THE ASPF GROUP AND 27 PATIENTS IN THE ORIF GROUP. THE AVERAGE AGE OF PATIENTS WAS 49.4 +/-12.1 YEARS IN THE ASPF GROUP AND 46.9 +/- 11.4 YEARS IN THE ORIF GROUP. THERE WERE 13 MEN AND 6 WOMEN IN THE ASPF GROUP, AND 20 MEN AND 7 WOMEN IN THE ORIF GROUP. ALL PATIENTS IN THE ORIF GROUP WERE IMPLANTED WITH AN UNKNOWN SYNTHES PROXIMAL HUMERUS INTERNAL LOCKING SYSTEM PLATE (PHILOS) ALONG WITH BRAIDED SUTURES THAT WERE TIED TO THE PLATE THROUGH THE SUTURE EYELETS FOR SUPPLEMENTAL FIXATION OF THE GREATER TUBEROSITY FRACTURE. MEANWHILE, PATIENTS IN ASPF GROUP WERE IMPLANTED WITH A COMPETITOR¿S DEVICE. THE POSTOPERATIVE REHABILITATION REGIME WAS SIMILAR FOR THE ASPF AND ORIF GROUPS. THE AFFECTED UPPER EXTREMITY WAS SUPPORTED BY A SLING BANDAGE FOR 4 WEEKS AFTER SURGERY. THE PATIENTS WERE ALLOWED TO BEGIN PASSIVE EXERCISES FROM THE SECOND POSTOPERATIVE DAY. THE ACTIVE ASSISTANT EXERCISES WERE INITIATED FROM 6 WEEKS AFTER SURGERY. ACTIVE RESISTANCE EXERCISES WERE USUALLY STARTED 3 MONTHS POSTOPERATIVELY OR WHEN RADIOGRAPHIC EVIDENCE SHOWED FRACTURE HEALING. THE MEAN FOLLOW-UP WAS SIMILAR FOR THE ASPF (19.4 +/- 3.7 MONTHS) AND THE ORIF (18.2 +/-3.2 MONTHS) GROUPS. COMPLICATIONS WERE REPORTED: 2 PATIENTS HAD POSTOPERATIVE SHOULDER STIFFNESS. SHOULDER STIFFNESS WERE MANIPULATED TO RELEASE ADHESION UNDER ANESTHESIA. PATIENT¿S OBTAINED SATISFACTORY SHOULDER FUNCTION AFTER MANIPULATION, BASED ON THEIR SELF-EVALUATION. 2 PATIENTS HAD FRACTURE MALUNION. PATIENTS UNDERWENT REOPERATION, AND STABLE FIXATION AND BONE UNION WAS ACHIEVED. 1 PATIENT HAD SUBACROMIAL IMPINGEMENT. THE PATIENTS HAD SUBSEQUENT RELIEF OF IMPINGEMENT SYMPTOMS AFTER REMOVAL OF THE PLATE. THIS REPORT IS FOR THE UNKNOWN SYNTHES PROXIMAL HUMERUS INTERNAL LOCKING SYSTEM PLATE (PHILOS). THIS REPORT IS FOR (1) UNK - CONSTRUCTS: PHILOS PLATE/SCREWS. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871661 UNK - CONSTRUCTS: PHILOS PLATE/SCREWS SCREW,FIXATION,BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention