BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 6770463 · Received August 7, 2017

    Report

    Report Number
    2520274-2017-12051
    Event Type
    Injury
    Date Received
    August 7, 2017
    Report Date
    August 2, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. EDER, C; SCHWAB, N; SCHELLER, A; KRAPOHL, B (2015) A NEW VARIANT OF SCAPHOID RECONSTRUCTION: TREATMENT OF SCAPHOID NON-UNION WITH AVASCULAR BONE INTERPONATE AND HIGH COMPRESSION SCREW (SYNTHES). GMS INTERDISCIPLINARY PLASTIC & RECONSTRUCTIVE SURGERY DGPW, 4:1-8. THIS REPORT IS FOR AN UNKNOWN COMPRESSION SCREW (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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: EDER, C; SCHWAB, N; SCHELLER, A; KRAPOHL, B (2015) A NEW VARIANT OF SCAPHOID RECONSTRUCTION: TREATMENT OF SCAPHOID NON-UNION WITH AVASCULAR BONE INTERPONATE AND HIGH COMPRESSION SCREW (SYNTHES). GMS INTERDISCIPLINARY PLASTIC & RECONSTRUCTIVE SURGERY DGPW, 4:1-8. THIS IS A RETROSPECTIVE STUDY TO EVALUATE THE SHORT AND LONG-TERM OUTCOME OF A MODIFIED TREATMENT OF SCAPHOID NON-UNION BY USING THE HIGH COMPRESSION SCREW AND AUTOLOGOUS AVITAL (ILIAC BONE, RADIUS) INTERPOSITION IN COMPARISON TO OTHER PROCEDURES. BETWEEN 2011 AND 2013, 22 PATIENTS (AVERAGE AGE OF 30.27 YEARS, 18 MALES AND 4 FEMALE) WITH SCAPHOID NONUNION WERE DIAGNOSED AND TREATED WITH THE HIGH COMPRESSION SCREW. ALL OF THESE, 22 PATIENTS UNDERWENT SURGERY WITH THE MODIFIED SCAPHOID RECONSTRUCTION TECHNIQUE USING AN ILIAC CREST BONE GRAFT COMBINED WITH THE HIGH COMPRESSION SCREW (HCS SYNTHES). CONCERNING TO THE DIFFERENT NONUNION EXTENTS, 20 PATIENTS GOT AUTOLOGOUS ILIAC CREST INTERPONATES (90.9%), ONE GOT AUTOLOGOUS DISTAL RADIUS INTERPONATES (4.55%) AND ONE PATIENT WAS TREATED WITHOUT ANY BONY INTERPONATE (4.55%). IN SHORT-TERM EVALUATION, 3 MONTHS AFTER OPERATION, 17 PATIENTS (80.95%) IMPOSED WITH INCIPIENT BONY HEALING OF SCAPHOID NONUNION IN AVERAGE 3 MONTHS AFTER OPERATION. THREE PATIENTS WITH PERSISTING FRACTURE GAP HAVE HAD THE SCAPHOID BONE FRACTURED IN THE PROXIMAL THIRD; ONE PATIENT WITH A VERY SMALL PROXIMAL FRAGMENT. ONE PERSISTING NON-UNION WAS LOCALIZED IN THE MIDDLE THIRD (PERIOD BETWEEN INJURY AND OPERATION WAS 5 YEARS). IN LONG-TERM EVALUATION, THREE PATIENTS WITH PERSISTING FRACTURE GAP ARE INCLUDED. TWO PATIENTS NOTICED DYSESTHESIA AFTER HEAVY BURDEN. THIS IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN COMPRESSION SCREW AND REFERS TO THE SERIOUS INJURY OF 3 UNKNOWN PATIENTS WITH PERSISTENT FRACTURE GAP, 1 WITH SMALL PROXIMAL FRACTURE, 1 WITH PERSISTENT NON-UNION, AND 5 WITH PAIN AFTER HEAVY BURDEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551242 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention