BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 7003541 · Received November 6, 2017

    Report

    Report Number
    2520274-2017-12581
    Event Type
    Injury
    Date Received
    November 6, 2017
    Date of Event
    January 24, 2017
    Report Date
    October 17, 2017
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    I. REPETTO ET AL (2017) SURGICAL MANAGEMENT OF COMPLEX PROXIMAL HUMERAL FRACTURES: PINNING, LOCKED PLATE AND ARTHROPLASTY. MUSCULOSKELETAL SURGERY, VOLUME 101, PAGES 153-158. THIS REPORT IS FOR AN UNKNOWN UNKNOWN PHILOS LOCKED COMPRESSION PLATES (UNKNOWN QUANTITY/UNKNOWN LOT). (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA. 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 SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: I. REPETTO ET AL (2017) SURGICAL MANAGEMENT OF COMPLEX PROXIMAL HUMERAL FRACTURES: PINNING, LOCKED PLATE AND ARTHROPLASTY. MUSCULOSKELETAL SURGERY, VOLUME 101, PAGES 153-158. THE PURPOSE OF THE ARTICLE WAS TO COMPARE THE CLINICAL RESULTS AND RELATED COMPLICATIONS OF FOUR DIFFERENT SURGICAL TREATMENTS FOR COMPLEX PROXIMAL HUMERAL FRACTURES. BETWEEN 2007 AND 2011, 92 CONSECUTIVE PATIENTS WERE DIAGNOSED FOR COMPLEX HUMERAL FRACTURES OF WHICH 21 PATIENTS HAD THREE-PART FRACTURES, 37 PATIENTS HAD FOUR-PART FRACTURES, 11 PATIENTS HAD HEAD-SPLITTING FRACTURES AND 23 PATIENTS HAD FRACTURE-DISLOCATION. THE MEAN FOLLOW-UP WAS 38.7 ± 17.0 MONTHS (12¿78 MONTHS). ABOUT 22/92 PATIENTS UNDERWENT CLOSED REDUCTION INTERNAL FIXATION (CRIF) USING PINNING TECHNIQUE WITH KIRSCHNER WIRES. A 19/92 PATIENTS UNDERWENT OPEN REDUCTION INTERNAL FIXATION, ORIF USING LOCKED COMPRESSION PLATES, (PHILOS PLATE, DEPUY SYNTHES, (B)(4)). 17/92 PATIENTS UNDERWENT HEMIARTHROPLASTY (HA) USING NEER II PROSTHESIS (3 M, (B)(4)) AND 7/92 PATIENTS UNDERWENT HEMIARTHROPLASTY USING A SMR MODULAR PROSTHESIS USING (LIMALTO, (B)(4)). A 27/92 PATIENTS RECEIVED REVERSE SHOULDER ARTHROPLASTY (RSA) USING CEMENTLESS SMR MODULAR PROSTHESIS (LIMA-LTO, (B)(4)). POSTOPERATIVELY, 7 PATIENTS WITH LOCKED COMPRESSION PLATES, (PHILOS PLATE, DEPUY SYNTHES, (B)(4)) PRESENTED WITH THE FOLLOWING COMPLICATIONS: 4 PATIENTS HAD AVASCULAR NECROSIS, 1 PATIENT HAD TRANSIENT CIRCUMFLEX NERVE PALSY AND 2 PATIENTS HAD PLATE IMPINGEMENT WITH THE ACROMION, 3 PATIENTS REQUIRED REVISION SURGERY (REVERSE SHOULDER ARTHROPLASTY). THIS REPORT IS FOR AN UNKNOWN LOCKED COMPRESSION PLATES, (PHILOS PLATE, DEPUY SYNTHES, (B)(4)). THIS REPORT IS FOR ONE (1) DEVICE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783685 PLATE, FIXATION, BONE HRS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention