BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 8670797 · Received June 5, 2019

    Report

    Report Number
    8030965-2019-64921
    Event Type
    Injury
    Date Received
    June 5, 2019
    Report Date
    May 7, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SYNTHES MATRIX ORTHOGNATHIC 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. 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: NAROS, A. ET AL (2019), A PROSPECTIVE HISTOMORPHOMETRIC AND CEPHALOMETRIC COMPARISON OF BOVINE BONE SUBSTITUTE AND AUTOGENOUS BONE GRAFTING IN LE FORT I OSTEOTOMIES, JOURNAL OF CRANIO-MAXILLO-FACIAL SURGERY, VOL. 47 (NO. 2), PAGES 233-238 (GERMANY). THE AIM OF THIS STUDY IS THE HISTOMORPHOMETRIC AND CEPHALOMETRIC COMPARISON OF BIO-OSS® BLOCK APPLICATION AND AUTOGENOUS BONE GRAFTING OF THE ANTERIOR ILIAC CREST (GOLD STANDARD) CONCERNING NEW BONE FORMATION AND POSTOPERATIVE STABILITY IN PATIENTS UNDERGOING ORTHOGNATHIC LE FORT I OSTEOTOMY. A TOTAL OF 25 PATIENTS, WITH AN AVERAGE AGE OF 26.1 ± 9.7 YEARS (RANGE 17-55), WERE INCLUDED IN THE STUDY. SURGERY PERFORMED USING MINIPLATES AND SCREWS (SYNTHES, MATRIX ORTHOGNATHIC, UMKIRCH, GERMANY). PATIENTS UNDERWENT PERIODIC FOLLOW-UP AT REGULAR INTERVALS AS PER DEPARTMENTAL PROTOCOL. AFTER A HEALING PERIOD OF AT LEAST SIX MONTHS (AVERAGE 11.6 ± 5.7 MONTHS), PROPHYLACTICALLY ALL OSTEOSYNTHESIS MATERIAL WAS REMOVED. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: ONE PATIENT IN THE INTER GROUP DEVELOPED A LATE ABSCESS AND PSEUDARTHROSIS. IN GENERAL ANESTHESIA THE MAXILLARY SINUS WAS INSPECTED, AND THE BONE SUBSTITUTE MATERIAL WAS REMOVED. OSTEOSYNTHESIS MATERIAL WAS PARTIALLY LOOSE AND WAS REMOVED ALSO. THE OSTEOTOMY GAP WAS BRIDGED WITH AUTOLOGOUS PELVIC BONE. CEPHALOMETRIC ANALYSIS: PATIENTS IN THE INTER (3.6 DEGREES ± 1.22 DEGREES) AND ONLAY-GROUP (4.7 DEGREES ± 3.47 DEGREES) UNDERWENT A LARGER MAXILLARY ADVANCEMENT (SNA; T1 TO T2) COMPARED TO CONTROL GROUP (BONE 2.4 DEGREES ± 1.15 DEGREES). HOWEVER, DESPITE THE LARGER OSTEOTOMY GAP, POSTOPERATIVE STABILITY (SNA; T2 TO T3) SHOWED COMPARABLE RESULTS IN ALL THREE GROUPS (INTER 0.73 DEGREES ± 0.37 DEGREES; ONLAY 1.4 DEGREES ± 0.96 DEGREES; BONE 0.78 DEGREES ± 0.59 DEGREES). THIS RESULTS IN A POSTOPERATIVE RELAPSE IN THE ANTERO-POSTERIOR DIRECTION OF 20.5 PERCENT (INTER), 30.3 PERCENT (ONLAY) AND 33.0 PERCENT (BONE), RESPECTIVELY. CONCERNING THE MAXILLARY INCLINATION (NL-NSL), THE ONLAY POSITIONING SHOWED THE WEAKEST PROTECTING EFFECT ON POSTOPERATIVE RELAPSE. HISTOMORPHOMETRIC ANALYSIS: REGARDING THE NEW BONE FORMATION (NBF) RESULTS REVEALED DIFFERENCES IN BETWEEN GROUPS: INTER 23.3 PERCENT (±14.1), ONLAY 14.9 PERCENT (±18.2) AND BONE 48.7 PERCENT (±27.8). HOWEVER, ALL GROUPS SHOWED COMPARABLE COMPLETE MINERALIZED FRACTIONS - THE SUM OF BOVINE BONE MINERAL (BBM) AND NBF OR RESIDUAL BONE AND NBF- IN BONE BIOPSIES OF INTER 50.2 PERCENT (±13.2), ONLAY 46.48 PERCENT (±12.3) AND BONE 57.1 PERCENT (±20.6) AS WELL AS COMPARABLE PERCENTAGE OF CONNECTIVE TISSUE (TABLE 2). THIS REPORT CAPTURES THE REPORTED PATIENT WHO DEVELOPED A LATE ABSCESS AND PSEUDARTHROSIS. UPON INSPECTION, THE OSTEOSYNTHESIS MATERIAL WAS PARTIALLY LOOSE AND WAS REMOVED. THIS REPORT IS FOR AN UNKNOWN SYNTHES MATRIX ORTHOGNATHIC SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465979 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention