BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3904983 · Received July 1, 2014

    Report

    Report Number
    2520274-2014-12000
    Event Type
    Injury
    Date Received
    July 1, 2014
    Report Date
    June 11, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT: 23 PATIENTS. PATIENT AGE: MEAN AGE 46. GENDER: 18 MALE, 5 FEMALE. WEIGHT NOT REPORTED. SCHWAB, J., ZEBRACK, J., SCHMELING, G., & JOHNSON, J. (2011). THE USE OF CERVICAL VERTEBRAE PLATES FOR CORTICAL SUBSTITUTION IN POSTERIOR WALL ACETABULAR FRACTURES. JOURNAL OF ORTHOP TRAUMA (25), 9, 577-580. THIS REPORT IS FOR UNKNOWN NONLOCKING CERVICAL VERTEBRAE PLATES, UNKNOWN PART AND UNKNOWN LOT NUMBERS. IMPLANT DATE: UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. 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 JOURNAL ARTICLE ¿THE USE OF CERVICAL VERTEBRAE PLATES FOR CORTICAL SUBSTITUTION IN POSTERIOR WALL ACETABULAR FRACTURES.¿ SCHWAB, J., ZEBRACK, J., SCHMELING, G., AND JOHNSON, J. JOURNAL OF ORTHOP TRAUMA, VOLUME 25, NUMBER 9, SEPTEMBER 2011. TWENTY-THREE PATIENTS BETWEEN 2001 AND 2005 WITH ISOLATED POSTERIOR WALL ACETABULAR FRACTURES REQUIRING SURGICAL FIXATION WERE TREATED USING A NEW TECHNIQUE FOR OPERATIVE FIXATION OF POSTERIOR WALL ACETABULAR FRACTURES THAT REQUIRE CORTICAL SUBSTITUTION. A RETROSPECTIVE REVIEW OF THE CHARTS FOR THESE PATIENTS WAS DONE. THE AVERAGE AGE OF THE 23 PATIENTS AT THE TIME OF SURGERY WAS 46 YEARS. EIGHTEEN WERE MALE AND FIVE WERE FEMALE. SIXTEEN (69.5%) PATIENTS PRESENTED WITH A HIP DISLOCATION. THIS TECHNIQUE USED CERVICAL VERTEBRAE PLATES THAT ARE H-SHAPED AS AN ALTERNATIVE TO THE COMBINATION OF STANDARD LOCKING OR NONLOCKING PELVIC RECONSTRUCTION PLATES AND CORTICAL SUBSTITUTION PLATES, SPECIFICALLY, SPRING PLATES. THE CERVICAL VERTEBRAE PLATE USED WERE STAINLESS STEEL, CAME IN FOUR SIZES RANGING FROM FIVE HOLES TO 20 HOLES (25¿103 MM LENGTH), AND DID NOT USE LOCKING SCREW TECHNOLOGY. THE PATIENTS WERE PLACED IN THE PRONE POSITION ON A PELVIC TRACTION TABLE, AND DISTAL FEMORAL SKELETAL TRACTION IS APPLIED WITH THE HIP EXTENDED AND THE KNEE FLEXED TO 90°. FRACTURE FRAGMENTS WERE IDENTIFIED, AND AN INTRAOPERATIVE ASSESSMENT OF POSTERIOR WALL FRACTURE COMMINUTION WAS PERFORMED. THE JOINT WAS DISTRACTED; INTRA-ARTICULAR FRAGMENTS WERE REMOVED AND, WHEN POSSIBLE, USED IN THE RECONSTRUCTION. AFTER REMOVING ANY DISTRACTING FORCES FROM THE JOINT, MARGINAL IMPACTION OF THE ARTICULAR SURFACE WAS REDUCED TO RECREATE THE JOINT, AND THE REMAINING FRACTURE FRAGMENTS WERE REDUCED. THE CERVICAL VERTEBRAE PLATE WAS USED IN A FASHION SIMILAR TO STANDARD LOW-PROFILE PELVIC RECONSTRUCTION PLATES. THE PLATE COULD BE SHORTENED TO THE APPROPRIATE LENGTH BY CUTTING IT IF A PREFABRICATED PLATE IN THE APPROPRIATE SIZE WAS NOT AVAILABLE. THE PLATE WAS PROVISIONALLY CONTOURED TO THE REDUCED BONE USING MANUAL PLATE BENDERS. ONCE THE PLATE WAS PROVISIONALLY CONTOURED, IT WAS SECURED TO THE BONE BY PLACING SCREWS FROM ONE END TO THE OTHER, SEQUENTIALLY, OR BY STARTING IN THE MIDDLE AND PROGRESSING TO BOTH ENDS. THIS ALLOWED THE PLATE TO BE ¿¿SUCKED DOWN¿¿ TO THE BONE. IT IS ADVANTAGEOUS TO PLACE THE PLATE OVER THE AREA OF GREATEST COMMINUTION, BUT CARE SHOULD BE TAKEN TO PREVENT PLATE OVERHANG OF THE POSTERIOR WALL. A SINGLE CERVICAL VERTEBRAE PLATE WAS NOT ALWAYS SUFFICIENT TO ACT AS A CORTICAL SUBSTITUTE OVER THE ENTIRETY OF THE FRACTURE, AND A SECOND PLATE, TYPICALLY OF SHORTER LENGTH, WAS ADDED TO AUGMENT FIXATION. ALL PATIENTS WERE FOLLOWED RADIOGRAPHICALLY AND CLINICALLY FOR A MINIMUM OF 1 YEAR FROM THEIR INDEX SURGERY. THE INCIDENCE OF COMPLICATIONS INCLUDED OSTEONECROSIS 1 (4%), BROOKER 1 OR 2 HO 3 (13%), AND REVISION TO TOTAL HIP ARTHROPLASTY 2 (9%). IN THE OPINION OF THE AUTHORS THE ADVANTAGES OF THE CERVICAL VERTEBRAE PLATE INCLUDED CORTICAL SUBSTITUTION AND USING A SINGLE IMPLANT. THE MAJOR DRAWBACK TO THE USE OF THIS IMPLANT WAS THAT THERE ARE FEWER CHOICES FOR PLATE SIZE COMPARED WITH TRADITIONAL PELVIC RECONSTRUCTION PLATES. IN ADDITION, THE INABILITY TO CONTOUR THE IMPLANT LONGITUDINALLY LIMITED ITS USE. IN THIS RETROSPECTIVE REVIEW OF THE CHARTS OF ISOLATED POSTERIOR WALL ACETABULAR FRACTURES, THE CERVICAL VERTEBRAE PLATE PROVIDED CONSISTENTLY RELIABLE RESULTS COMPARABLE TO TRADITIONAL METHODS. THIS REPORT IS FOR 1 CASE OF OSTEONECROSIS. THIS REPORT IS FOR AN UNKNOWN NONLOCKING CERVICALE VERTEBRAE PLATE. THIS IS REPORT 1 OF 3 FOR (B)(4). (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384765 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention