BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: IMF

    MDR report key: 20185605 · Received September 10, 2024

    Report

    Report Number
    8030965-2024-11108
    Event Type
    Injury
    Date Received
    September 10, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. 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 · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: MAURER M, KLAES T, FIEDLER M, TAXIS J, SCHUDERER JG, WAISS W, GOTTSAUNER M, MEIER JK, REICHERT TE, ETTL T. PATIENT'S PERCEPTION OF OUTCOME AFTER EXTRACAPSULAR FRACTURES OF THE MANDIBULAR CONDYLE DIFFERS FROM OBJECTIVE EVALUATION-EXPERIENCE OF A THIRD-LEVEL HOSPITAL. J CLIN MED. 2024 FEB 28;13(5):1395. DOI: 10.3390/JCM13051395. PMID: 38592235; PMCID: PMC10931758. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY IS TO ASSESS PATIENTS¿ SUBJECTIVE PERCEPTION OF TREATMENT OUTCOME AFTER EXTRACAPSULAR FRACTURES OF THE MANDIBULAR CONDYLE. INCLUSION CRITERIA OF THE STUDY WERE TREATMENT OF AN UNI- OR BILATERAL EXTRACAPSULAR FRACTURE OF THE MANDIBULAR CONDYLE BETWEEN 1 JANUARY 2006 AND 31 DECEMBER 2020. CONSERVATIVE TREATMENT CONSISTED OF INTERMAXILLARY FIXATION BY IMF SCREWS (DEPUY SYNTHES, RAYNHAM, MA, USA) AND ELASTICS (HELAGO®, HEINZ UND LAUFER OHG, BONN, GERMANY). OSTEOSYNTHESIS WAS CARRIED OUT BY 2 MINIPLATES (MATRIX MANDIBLE ADAPTION PLATE, THICKNESS .0 MM COMBINED WITH 6 MM SCREWS, DEPUY SYNTHES, RAYNHAM, MA, USA). THE QUESTIONNAIRE WAS SENT TO 290 PATIENTS WHO UNDERWENT TREATMENT OF EXTRACAPSULAR FRACTURES OF THE MANDIBULAR CONDYLE. REPLIES WERE RECEIVED FROM 115 PATIENTS (46 FEMALE (40.0%); 69 MALE (60.0%)). THE RESPONSE RATE WAS 39.7%. THE MEAN AGE WAS 41.89 ± 16.59 YEARS (RANGE 18¿86 YEARS). THE CASES COULD BE SUBDIVIDED IN 62 UNILATERAL AND 53 BILATERAL FRACTURES. A TOTAL OF 107 OF THE 115 FRACTURES WERE TREATED BY ORIF (93.0%); 8 UNDERWENT CONSERVATIVE THERAPY (7.0%). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES IMF SCREWS AND MATRIX MANDIBLE ADAPTION PLATE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: MATRIXMANDIBLE PLATES AND SCREWS (QTY 360) (N=11) PATIENTS HAD A POSTSURGICAL FACIAL NERVE PALSY AFTER ORIF (N=33) PATIENTS HAD POST-TREATMENT MALOCCLUSION IN 3 MONTHS, NO INTERVENTION NOTED. (N=23) PATIENTS HAD POST-TREATMENT MALOCCLUSION IN 6 MONTHS, NO INTERVENTION NOTED. (N=18) PATIENTS HAD POST-TREATMENT MALOCCLUSION IN 12 MONTHS, NO INTERVENTION NOTED. (N=44) PATIENTS (38.3%) COMPLAINED PAIN IN CHEWING AND 18 PATIENTS (15.7%) REPORTED DURABLY OCCURRING PAIN AFTER SURGICAL OR NON-SURGICAL INTERVENTION. (N=55) PATIENTS HAD A POST-TREATMENT PAIN IN 3 MONTHS, NO INTERVENTION NOTED. (N=29) PATIENTS HAD A POST-TREATMENT PAIN IN 6 MONTHS, NO INTERVENTION NOTED. (N=19) PATIENTS HAD A POST-TREATMENT PAIN IN 12 MONTHS, NO INTERVENTION NOTED. (N=60) PATIENTS HAD A POST-TREATMENT MAXIMUM MOUTH OPENING (MMO) REDUCTION IN 3 MONTHS, NO INTERVENTION NOTED. (N=30) PATIENTS HAD A POST-TREATMENT MAXIMUM MOUTH OPENING (MMO) REDUCTION IN 6 MONTHS, NO INTERVENTION NOTED. (N=22) PATIENTS HAD A POST-TREATMENT MAXIMUM MOUTH OPENING (MMO) REDUCTION IN 12 MONTHS, NO INTERVENTION NOTED. (N=16) PATIENTS (13.9%) REPORTED SUFFERING FROM CEPHALGIA OR PAIN IN THE NECK MUSCLES, RESPECTIVELY, AND NECK TENSION SINCE THE TRAUMA, RESPECTIVELY, DURING TREATMENT. THIS WAS SIGNIFICANTLY ASSOCIATED WITH LONG-TERM OCCLUSAL DISHARMONY, MMO REDUCTION, LONG-TERM PAIN AT THE FRACTURE SITE , AND POST-TREATMENT MANDIBULAR DEVIATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: IMF (QTY 88) (N=3) PATIENTS HAD POST-TREATMENT MALOCCLUSION IN 3 MONTHS, NO INTERVENTION NOTED. (N=1) PATIENTS HAD POST-TREATMENT MALOCCLUSION IN 6 MONTHS, NO INTERVENTION NOTED. (N=1) PATIENTS HAD POST-TREATMENT MALOCCLUSION IN 12 MONTHS, NO INTERVENTION NOTED. (N=44) PATIENTS (38.3%) COMPLAINED PAIN IN CHEWING AND 18 PATIENTS (15.7%) REPORTED DURABLY OCCURRING PAIN AFTER SURGICAL OR NON-SURGICAL INTERVENTION. (N=7) PATIENTS HAD A POST-TREATMENT PAIN IN 3 MONTHS, NO INTERVENTION NOTED. (N=4) PATIENTS HAD A POST-TREATMENT PAIN IN 6 MONTHS, NO INTERVENTION NOTED. (N=3) PATIENTS HAD A POST-TREATMENT PAIN IN 12 MONTHS, NO INTERVENTION NOTED. (N=4) PATIENTS HAD A POST-TREATMENT MAXIMUM MOUTH OPENING (MMO) REDUCTION IN 3 MONTHS, NO INTERVENTION NOTED. (N=3) PATIENTS HAD A POST-TREATMENT MAXIMUM MOUTH OPENING (MMO) REDUCTION IN 6 MONTHS, NO INTERVENTION NOTED. (N=2) PATIENTS HAD A POST-TREATMENT MAXIMUM MOUTH OPENING (MMO) REDUCTION IN 12 MONTHS, NO INTERVENTION NOTED. (N=16) PATIENTS (13.9%) REPORTED SUFFERING FROM CEPHALGIA OR PAIN IN THE NECK MUSCLES, RESPECTIVELY, AND NECK TENSION SINCE THE TRAUMA, RESPECTIVELY, DURING TREATMENT. THIS WAS SIGNIFICANTLY ASSOCIATED WITH LONG-TERM OCCLUSAL DISHARMONY, MMO REDUCTION, LONG-TERM PAIN AT THE FRACTURE SITE , AND POST-TREATMENT MANDIBULAR DEVIATION. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251648 UNK - SCREWS: IMF SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention