BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 8331974 · Received February 12, 2019

    Report

    Report Number
    8030965-2019-60926
    Event Type
    Injury
    Date Received
    February 12, 2019
    Date of Event
    November 12, 2018
    Report Date
    January 25, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN SYNTHES SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: H. FRIMA ET AL (2018), "LONG-TERM FOLLOW-UP AFTER MIPO PHILOS PLATING FOR PROXIMAL HUMERUS FRACTURES." ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, PAGES 1-7 (SWITZERLAND). THE AIM OF THIS STUDY WAS TO ANALYZE THE LONG-TERM FUNCTIONAL OUTCOME AFTER MIPO WITH PHILOS FOR PROXIMAL HUMERUS FRACTURES. BETWEEN DECEMBER 2007 AND OCTOBER 2010, 191 PATIENTS WITH A PROXIMAL HUMERUS FRACTURE WERE TREATED WITH MIPO THROUGH A ¿DELTOID SPLIT¿ APPROACH IN OUR CENTER USING THE PHILOS® SYSTEM (SYNTHES, SWITZERLAND). A TOTAL OF 79 (81%) PATIENTS WERE AVAILABLE FOR FOLLOW-UP AND INCLUDED FOR ANALYSIS. THE MEAN AGE AT THE TIME OF ACCIDENT WAS 59 (SD ± 13) YEARS AND 37 (47%) PATIENTS WERE MALE. THERE WERE 16 (20%) TYPE A, 33 (42%) TYPE B, AND 30 (38%) TYPE C FRACTURES ACCORDING TO THE AO CLASSIFICATION. THE PRIMARY OUTCOME MEASURE WAS SHOULDER FUNCTION AS MEASURED BY THE QUICKDASH SCORE AND THE SECONDARY OUTCOME MEASURES WERE SSV AND IMPLANT-RELATED IRRITATION OR IMPLANT REMOVAL. THE MEAN TIME TO DIAGNOSIS WAS 16.7 MONTHS, THE MEAN RADIOLOGICAL FOLLOW-UP WAS 34 MONTHS. THE MEAN FOLLOW-UP DURATION WAS 8.3 YEARS (SD 0.8). THE COMPLICATIONS WERE REPORTED AS FOLLOWS: 7 PATIENTS HAD SECONDARY SCREW PERFORATION ON AVERAGE 7 WEEKS POSTOPERATIVELY AND REQUIRED OPERATIVE SCREW REPLACEMENT. 4 PATIENTS HAD AXILLARY NERVE INJURY WITH ATROPHY OF THE ANTERIOR BORDER OF THE DELTOID MUSCLE, HOWEVER, WITHOUT CLINICAL CONSEQUENCES. 8 PATIENTS DEVELOPED SOME DEGREE OF RADIOLOGICAL AVASCULAR NECROSIS (AVN) (GRADE 3-5) IN SHORT-TERM FOLLOW-UP. FIVE PATIENTS WITH AVN WERE AVAILABLE FOR LONG-TERM FOLLOW-UP. OF ALL PATIENTS WITH AVN THREE HAD A SCREW PERFORATION OF THE HEAD AND FOUR HAD THEIR IMPLANT REMOVED. 1 PATIENT HAD A QUICKDASH SCORE OF 73 AND WAS OFFERED A REVERSED ARTHROPLASTY BUT THE PATIENT REFUSED. 1 PATIENT WITH AVN GRADE 5 WITH A QUICKDASH SCORE OF 13 AND AN SSV OF 60 IS CONSIDERING A REVERSED ARTHROPLASTY. UNKNOWN PATIENT HAD IRRITATION BUT IMPLANT REMOVAL WAS NOT NECESSARY. UNKNOWN PATIENT HAD IRRITATION AND NO REQUEST FOR REMOVAL WAS DONE DUE TO FEAR OF SURGERY. UNKNOWN PATIENT UNDERWENT IMPLANT REMOVAL DUE TO IMPLANT IRRITATION. 1 PATIENT RECEIVED A REVERSED ARTHROPLASTY DUE TO A SYMPTOMATIC MALUNION. 1 PATIENT DEVELOPED A RECURRENT SHOULDER DISLOCATION. 1 PATIENT DEVELOPED A RECURRENT SHOULDER DISLOCATION AND WAS OPERATED FOR A ROTATOR CUFF REPAIR. UNKNOWN PATIENTS DIED AND WERE LOST TO FOLLOW-UP. FOR THE YEAR 2013, THERE WAS 2 AND 8 FOR THE YEAR 2017. THIS REPORT CAPTURES THE 4 PATIENTS WHO HAD AXILLARY NERVE INJURY WITH ATROPHY OF THE ANTERIOR BORDER OF THE DELTOID MUSCLE, HOWEVER, WITHOUT CLINICAL CONSEQUENCES; 8 PATIENTS WHO DEVELOPED SOME DEGREE OF RADIOLOGICAL AVASCULAR NECROSIS (AVN) (GRADE 3-5) IN SHORT-TERM FOLLOW-UP. FIVE PATIENTS WITH AVN; 1 PATIENT WHO DEVELOPED A RECURRENT SHOULDER DISLOCATION AND 1 PATIENT WHO DEVELOPED A RECURRENT SHOULDER DISLOCATION AND WAS OPERATED FOR A ROTATOR CUFF REPAIR. THIS REPORT IS FOR AN UNKNOWN SYNTHES SCREWS. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125082 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention