BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 7670157 · Received July 9, 2018

    Report

    Report Number
    8030965-2018-54863
    Event Type
    Injury
    Date Received
    July 9, 2018
    Report Date
    June 12, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR ONE (1) UNKNOWN PLATE. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR ONE (1) UNKNOWN PLATE. PMA/510(K) NUMBER IS NOT AVAILABLE. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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: CHAN L. ET AL (2018) NON-PROSTHETIC PERI-IMPLANT FRACTURES: CLASSIFICATION, MANAGEMENT AND OUTCOMES. ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY VOLUME 138, PAGES 791-802 (SINGAPORE). THE AIMS OF THIS RETROSPECTIVE STUDY WERE TO REVIEW PATTERNS OF INJURY, MANAGEMENT AND OUTCOMES AND TO ATTEMPT TO CLASSIFY NON-PROSTHETIC PERI-IMPLANT FRACTURE (NPPIFS) INTO A SYSTEM THAT MAY AID FURTHER RESEARCH AND STUDY. A NON-PROSTHETIC PERI-IMPLANT FRACTURE (NPPIF) IS DEFINED AS A FRACTURE IN A BONE WITH AN EXISTING NON-PROSTHETIC IMPLANT SUCH AS AN EXTRAMEDULLARY PLATE AND SCREWS OR AN INTRAMEDULLARY NAIL. A TOTAL OF 53 PATIENTS 31 MALES AND 22 FEMALES WITH A MEAN AGE OF 64 YEARS (60 TOTAL NPPIFS) WERE INCLUDED IN THIS STUDY. OF THE 53 PATIENTS, 27 PATIENTS WERE REVISED WITH UNKNOWN SYNTHES DEVICES. AVERAGE FOLLOW-UP WAS 16 MONTHS (RANGE 0¿75). THE FOLLOWING POST-OPERATIVE COMPLICATIONS WERE OBSERVED. A (B)(6) MALE PATIENT, INITIALLY IMPLANTED WITH A COMPETITOR DEVICE OBTAINED NPPIF (FEMUR SHAFT) FRACTURE. PATIENT WAS REVISED WITH AN UNKNOWN SYNTHES LISS PLATE DISTAL FEMUR. THE PATIENT PRESENTED NON-UNION AT 75TH MONTH POST-OP FOLLOW-UP. A (B)(6) FEMALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES DHS OBTAINED NPPIF (INTERTROCHANTERIC) FRACTURE DUE TO A LOW VELOCITY FALL. PATIENT WAS REVISED WITH AN UNKNOWN SYNTHES LISS PLATE DISTAL FEMUR. THE PATIENT DIED AT 3 MONTHS POST-SURGERY AND WAS ALSO DIAGNOSED WITH PNEUMONIA. AN (B)(6) FEMALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES DHS OBTAINED NPPIF (INTERTROCHANTERIC) FRACTURE DUE TO A LOW VELOCITY FALL. PATIENT WAS REVISED WITH AN UNKNOWN SYNTHES LISS PLATE DISTAL FEMUR. THE PATIENT PRESENTED DEEP VEIN THROMBOSIS AT 5TH MONTH POST-OP FOLLOW-UP. A (B)(6) FEMALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES DHS OBTAINED NPPIF (INTERTROCHANTERIC) FRACTURE DUE TO A LOW VELOCITY FALL. PATIENT WAS REVISED WITH AN UNKNOWN SYNTHES ANTEGRADE FEMORAL NAIL, NO COMPLICATIONS WERE REPORTED AFTER REVISION SURGERY. AN (B)(6) FEMALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES DHS OBTAINED NPPIF (INTERTROCHANTERIC) FRACTURE DUE TO A LOW VELOCITY FALL. PATIENT WAS REVISED WITH AN UNKNOWN SYNTHES ANTEGRADE FEMORAL NAIL, NO COMPLICATIONS WERE REPORTED AFTER REVISION SURGERY. A (B)(6) MALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES LCDCP OBTAINED NPPIF (FEMUR SHAFT) FRACTURE DUE TO A LOW VELOCITY FALL. PATIENT WAS REVISED WITH AN UNKNOWN SYNTHES A2FN ANTEGRADE FEMORAL NAIL. THE PATIENT PRESENTED NON-UNION AT 10TH MONTH POST-OP FOLLOW-UP, WHICH NEEDED DYNAMIZATION. A (B)(6) MALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES DCS OBTAINED NPPIF (ITA WITH ST EXTENSION/ FEMUR SHAFT) FRACTURE DUE TO A LOW VELOCITY FALL. PATIENT WAS REVISED WITH AN UNKNOWN SYNTHES LONG DCS, NO COMPLICATIONS WERE REPORTED AFTER REVISION SURGERY. A (B)(6) MALE PATIENT, INITIALLY IMPLANTED WITH A COMPETITOR DEVICE OBTAINED NPPIF DUE TO A LOW VELOCITY FALL AND WAS REVISED WITH AN UNKNOWN SYNTHES LISS PLATE DISTAL FEMUR. THE PATIENT HAD REFRACTURE AND UNDERWENT REOPERATION, WHICH UNITED AT 8 MONTHS POST-OP. AN (B)(6) MALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES DHSS-LONG OBTAINED NPPIF (SHAFT) FRACTURE DUE TO A LOW VELOCITY FALL. PATIENT WAS REVISED WITH A COMPETITOR DEVICE, NO COMPLICATIONS WERE REPORTED AFTER REVISION SURGERY. A (B)(6) MALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES LCDCP OBTAINED NPPIF (FEMUR SHAFT) FRACTURE DUE TO A LOW VELOCITY FALL. PATIENT WAS REVISED WITH AN UNKNOWN SYNTHES LONG DHS WITH GREATER TROCHANTER SCREW. THE PATIENT PRESENTED PERI-IMPLANT FRACTURE TWICE WITH REOPERATIONS AT 14TH MONTH POST-OP FOLLOW-UP. A (B)(6) MALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES LCP OBTAINED NPPIF (HUMERUS SHAFT) FRACTURE DUE TO A LOW VELOCITY FALL. PATIENT WAS REVISED WITH A COMPETITOR DEVICE, NO COMPLICATIONS WERE REPORTED AFTER REVISION SURGERY. A (B)(6) FEMALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES LISS PLATE OBTAINED NPPIF (SUPRACONDYLAR ABOVE TKR) FRACTURE DUE TO A LOW VELOCITY FALL. PATIENT WAS REVISED WITH A COMPETITOR DEVICE, NO COMPLICATIONS WERE REPORTED AFTER REVISION SURGERY. A (B)(6) MALE PATIENT, INITIALLY IMPLANTED WITH A COMPETITOR DEVICE OBTAINED INTRA-OP FRACTURE OF THE INTERTROCHANTER. PATIENT WAS REVISED WITH AN UNKNOWN SYNTHES LONG PFNA. THE PATIENT PRESENTED DEEP VEIN THROMBOSIS AT 5TH MONTH POST-OP FOLLOW-UP. A (B)(6) MALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES NARROW LCDCP OBTAINED NPPIF (HUMERUS SHAFT) FRACTURE DUE TO A ROAD TRAFFIC ACCIDENT. PATIENT WAS REVISED WITH AN UNKNOWN SYNTHES NARROW LCDCP, NO COMPLICATIONS WERE REPORTED AFTER REVISION SURGERY. A (B)(6) FEMALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES LCDCP OBTAINED NPPIF (RIGHT RADIUS AND ULNA AND LEFT RADIUS AND ULNA) FRACTURES DUE TO LOW ENERGY FALL. PATIENT WAS REVISED WITH AN UNKNOWN SYNTHES 3.5 LCDCP. PATIENT EXPERIENCED REFRACTURE TWICE ON BOTH RADIUS AND ULNA OF THE LEFT AND RIGHT UPPER EXTREMITY WHICH REQUIRED REVISION. A (B)(6) FEMALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES DHS OBTAINED NPPIF (INTERTROCHANTERIC) FRACTURE DUE TO A LOW VELOCITY FALL. PATIENT WAS REVISED WITH A COMPETITOR DEVICE, NO COMPLICATIONS WERE REPORTED AFTER REVISION SURGERY. A (B)(6) FEMALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES DCS OBTAINED NPPIF (DISTAL FEMUR) FRACTURE AND A BROKEN SCREW DUE TO A LOW VELOCITY FALL. PATIENT WAS REVISED WITH A COMPETITOR DEVICE, NO COMPLICATIONS WERE REPORTED AFTER REVISION SURGERY. A (B)(6) MALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES LOW BEND DISTAL TIBIAL PLATE OBTAINED NPPIF (DISTAL TIBIA-FIBULA) FRACTURE DUE TO A ROAD TRAFFIC ACCIDENT. PATIENT WAS REVISED WITH A COMPETITOR DEVICE, NO COMPLICATIONS WERE REPORTED AFTER REVISION SURGERY. A (B)(6) MALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES LCDCP OBTAINED NPPIF (HUMERUS SHAFT) FRACTURE DUE TO A LOW ENERGY FALL. PATIENT WAS REVISED WITH AN UNKNOWN SYNTHES LCDCP, NO COMPLICATIONS WERE REPORTED AFTER REVISION SURGERY. A (B)(6) FEMALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES DHS OBTAINED NPPIF (INTERTROCHANTERIC) FRACTURE DUE TO A LOW VELOCITY FALL. PATIENT WAS REVISED WITH A COMPETITOR DEVICE, NO COMPLICATIONS WERE REPORTED AFTER REVISION SURGERY. AN (B)(6) FEMALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES DHS OBTAINED NPPIF (INTERTROCHANTERIC) FRACTURE OF THE RIGHT FEMUR DUE TO A LOW VELOCITY FALL. PATIENT WAS REVISED WITH A COMPETITOR DEVICE, NO COMPLICATIONS WERE REPORTED AFTER REVISION SURGERY. AN (B)(6) FEMALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES DHS OBTAINED NPPIF (INTERTROCHANTERIC) FRACTURE OF THE LEFT FEMUR DUE TO A LOW VELOCITY FALL. PATIENT WAS REVISED WITH AN UNKNOWN SYNTHES LONG PFNA, NO COMPLICATIONS WERE REPORTED AFTER REVISION SURGERY. A (B)(6) MALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES LONG PFNA OBTAINED NPPIF (INTERTROCHANTERIC) FRACTURE OF THE RIGHT FEMUR DUE TO A LOW ENERGY FALL. PATIENT WAS LOST TO FOLLOW-UP. A (B)(6) FEMALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES LISS PLATE OBTAINED NPPIF (SUPRACONDYLAR) FRACTURE OF THE FEMUR DUE TO A LOW ENERGY FALL. PATIENT WAS REVISED WITH AN UNKNOWN SYNTHES LONG PFNA, NO COMPLICATIONS WERE REPORTED AFTER REVISION SURGERY. A (B)(6) FEMALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES LCP OBTAINED NPPIF (ULNA SHAFT) FRACTURE DUE TO A LOW ENERGY FALL. PATIENT WAS LOST TO FOLLOW-UP. AN (B)(6) MALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES DCS OBTAINED NPPIF (INTERTROCHANTERIC) FRACTURE OF THE FEMUR DUE TO A ROAD TRAFFIC ACCIDENT. PATIENT WAS REVISED WITH AN UNKNOWN SYNTHES LISS PLATE, NO COMPLICATIONS WERE REPORTED AFTER REVISION SURGERY. A (B)(6) MALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES 3.5 MM LCDCP OBTAINED NPPIF (RADIUS SHAFT) FRACTURE DUE TO A ROAD TRAFFIC ACCIDENT. PATIENT WAS REVISED WITH AN UNKNOWN SYNTHES 3.5 MM LCDCP, NO COMPLICATIONS WERE REPORTED AFTER REVISION SURGERY. A (B)(6) MALE PATIENT, INITIALLY IMPLANTED WITH AN UNKNOWN SYNTHES 3.5 MM LCDCP OBTAINED NPPIF (RIGHT RADIUS AND ULNA SHAFT) FRACTURES DUE TO A LOW ENERGY FALL. PATIENT WAS UNDER CONSERVATIVE MANAGEMENT. THE RIGHT ULNA FRACTURE PRESENTED NON-UNION AFTER CONSERVATIVE MANAGEMENT . THIS REPORT IS FOR AN UNKNOWN PLATE FOR THE REPORTED NPPIF (RADIUS SHAFT) FRACTURE OF A (B)(6) MALE PATIENT. . THIS REPORT IS 2 OF 3 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS INCIDENT IS ALSO CAPTURED IN THE LINK COMPLAINTS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512343 PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention