BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING PLATE, SAGITTAL SPLIT, 6MM BAR, 6 HOLE, ORTHIOGNATHIC

    MDR report key: 12540777 · Received September 28, 2021

    Report

    Report Number
    0008010177-2021-00043
    Event Type
    Injury
    Date Received
    September 28, 2021
    Date of Event
    September 13, 2021
    Report Date
    March 17, 2022
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    UDI-DI
    04546540366245
    PMA / PMN Number
    K022185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT ¿BREAKAGE - POSTOPERATIVE¿ COULD NOT BE CONFIRMED, BECAUSE THE REVISION DATE FOR THE REMOVAL OF THE PLATE IS STILL UNKNOWN AND NO PICTURES (E.G. X-RAYS, CT-SCANS) OF THE BROKEN PLATE COULD BE PROVIDED AFTER SEVERAL REQUESTS. NEVERTHELESS, IT HAS BEEN REPORTED THAT 52-20404 AND 52-20504 (SCREWS) HAVE BEEN USED IN COMBINATION WITH THE PLATE UNDER COMPLAINT. THESE SCREWS ARE PART OF THE UNIVERSAL MANDIBLE SYSTEM AS THE PLATE. THUS, THESE ARE INTENDED TO BE APPLIED TOGETHER. LIMITED INFORMATION WAS PROVIDED BY THE SALES REP AS THE SALES REP COULD NOT MEET WITH THE CUSTOMER AND HE ALSO MENTIONED THAT THE CUSTOMER STOPPED RESPONDING TO HIS EMAILS. BASED ON THE PERFORMED STATISTICAL INVESTIGATION, THERE IS NO INDICATION FOR AN INCORRECTLY WORKING PRODUCT OR ANY SYSTEMATIC DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE. THEREFORE, NO CORRECTIVE AND / OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THAT TIME. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND. SHOULD THE DEVICE BE RETURNED, OR FURTHER INFORMATION BE AVAILABLE, THE INVESTIGATION WILL BE RE-EVALUATED. H3 OTHER TEXT : REVISION DATE FOR REMOVAL UNKNOWN.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE PATIENT HAD EXPERIENCED A PLATE BREAKAGE POSTOPERATIVELY. DUE TO THE PLATE BREAKAGE, A REVISION SURGERY WILL BE PERFORMED TO EXPLANT THE PLATE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENT HAD EXPERIENCED A PLATE BREAKAGE POSTOPERATIVELY. DUE TO THE PLATE BREAKAGE, A REVISION SURGERY WILL BE PERFORMED TO EXPLANT THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441845 LOCKING PLATE, SAGITTAL SPLIT, 6MM BAR, 6 HOLE, ORTHIOGNATHIC IMPLANT JEY STRYKER LEIBINGER FREIBURG 55-10554 1000451948 04546540366245

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention