BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI CORTEX SCREW SELF-TAPPING 24MM

    MDR report key: 7690933 · Received July 16, 2018

    Report

    Report Number
    8030965-2018-55047
    Event Type
    Injury
    Date Received
    July 16, 2018
    Report Date
    June 26, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819076112
    PMA / PMN Number
    K131186
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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.

    Additional Manufacturer Narrative · 0

    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. THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. THE INFORMATION IN THIS COMPLAINT RECORD REASONABLY SUGGESTS THAT THERE IS NO ALLEGATION OF A COMPLAINT AGAINST THIS DEVICE AND THERE IS NO REPORTED MALFUNCTION OR ADVERSE EVENT CAUSED OR CONTRIBUTED TO WITH THIS DEVICE. THE DEVICE FUNCTIONED AS INTENDED. SHOULD FURTHER INFORMATION BECOME AVAILABLE THIS DETERMINATION WILL BE REVIEWED. 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.

    Description of Event or Problem · 0

    CONCOMITANT DEVICES REPORTED: 3.5MM TI LOCKING SCREW SELF-TAPPING 30MM (PART 413.030, LOT L115506, QUANTITY 3), 3.5MM TI LOCKING SCREW SELF-TAPPING 30MM (PART 413.030, LOT L207879, QUANTITY 1), 3.5MM TI LOCKING SCREW SELF-TAPPING 30MM (PART 413.038, LOT L275096, QUANTITY 1), 3.5MM TI CORTEX SCREW 24MM (PART 404.024, LOT 9844343, QUANTITY 1), 3.5MM TI CORTEX SCREW 26MM (PART 404.026, LOT 9909005, QUANTITY 1), 3.5MM TI CORTEX SCREW 28MM (PART 404.028, LOT 9134808, QUANTITY 1), 3.5MM TI LCP® PLATE 12 HOLES 163MM (PART 423.621, LOT 9778619, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN. IT IS UNKNOWN IF THE REVISION SURGERY WAS COMPLETED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT REVISION SURGERY DUE TO AFTER POST-OPERATIVE BREAKAGE OF SCREWS. DURING THE REVISION, THEY KEPT THE PLATE IN PLACE AND REMOVED THE BROKEN SCREWS. PATIENT WAS IMPLANTED WITH NEW SCREWS. POST-OPERATIVE OF THIS REVISION SURGERY, ON AN UNKNOWN DATE, THREE SCREWS BROKE. NEW REVISION SURGERY WILL BE PERFORMED. PATIENT OUTCOME WAS NOT REPORTED. FIRST REVISION SURGERY FROM (B)(6) 2018 IS CAPTURED UNDER (B)(4). THIS PC CAPTURES THE BREAKAGE OF THREE SCREWS POST REVISION SURGERY. CONCOMITANT DEVICES REPORTED: PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); 3.5MM TI LOCKING SCREW SELF-TAPPING 24MM (PART# 413.024, LOT# UNKNOWN, QUANTITY 1); 3.5MM TI LOCKING SCREW SELF-TAPPING 30MM (PART# 413.030, LOT# UNKNOWN, QUANTITY 3); 3.5MM TI LOCKING SCREW SELF-TAPPING 30MM (PART# 413.038, LOT# UNKNOWN, QUANTITY 1); 3.5MM TI CORTEX SCREW SELF-TAPPING 26MM (PART# 404.826, LOT# UNKNOWN, QUANTITY 1); 3.5MM TI CORTEX SCREW SELF-TAPPING 28MM (PART# 404.828, LOT# UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) 3.5MM TI CORTEX SCREW SELF-TAPPING 24MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532312 3.5MM TI CORTEX SCREW SELF-TAPPING 24MM SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH 9844343 07611819076112

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention