BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI CORTEX SCREW SELF-TAPPING 55MM

    MDR report key: 10938124 · Received December 3, 2020

    Report

    Report Number
    8030965-2020-09347
    Event Type
    Injury
    Date Received
    December 3, 2020
    Report Date
    November 10, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    UDI-DI
    07611819133679
    PMA / PMN Number
    K131186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. 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

    THE ADVERSE EVENT WAS DISCOVERED ONE (1) MONTH AFTER THE PRIMARY SURGERY. THERE IS NO REVISION SURGERY SCHEDULED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE HWC. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. INVESTIGATION SUMMARY: 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. DEVICE HISTORY LOT: STERILE PART: PART: 404.855S, LOT: L992401, MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: AUG 20, 2018, EXPIRY DATE: JULY 01, 2028. SINCE THERE IS NO ALLEGATION AGAINST PACKING OR STERILITY DHR REVIEW IS DONE FOR NON-STERILE PART: NON-STERILE PART: PART: 404.855, LOT: L963853, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: JULY 02, 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT WAS OPERATED WITH AN OSTEOSYNTHESIS ON THE INFERIOR LIMBS IN (B)(6) 2020. SINCE (B)(6) 2020, THE PATIENT HAD AN ALLERGY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM TI CORTEX SCREW SELF-TAPPING 55MM THIS IS REPORT 8 OF 10 FOR COMPLAINT (B)(4). THIS COMPLAINT INVOLVES TOTAL 13 DEVICES. ADDITIONAL 03 DEVICES ARE REPORTED UNDER THE RELATED COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402426 3.5MM TI CORTEX SCREW SELF-TAPPING 55MM PLATE,FIXATION,BONE HRS SYNTHES GMBH L992401 07611819133679

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CANCELLOUSSCR Ø4 FULL-THR L14 TI| CANCELLOUSSCR Ø4 FULL-THR L18 TI| CANCELLOUSSCR Ø4 L50/15 TI| CORTSCR Ø3.5 SELF-TAP L14 TI| CORTSCR Ø3.5 SELF-TAP L14 TI| CORTSCR Ø3.5 SELF-TAP L14 TI| CORTSCR Ø3.5 SELF-TAP L26 TI| CORTSCR Ø3.5 SELF-TAP L45 TI| LCP ONE-THIRD TUBULAR PLATE 3.5, 6 HOLES| CANCELLOUSSCR Ø4 FULL-THR L14 TI| CANCELLOUSSCR Ø4 FULL-THR L18 TI| CANCELLOUSSCR Ø4 L50/15 TI| CORTSCR Ø3.5 SELF-TAP L14 TI| CORTSCR Ø3.5 SELF-TAP L14 TI| CORTSCR Ø3.5 SELF-TAP L14 TI| CORTSCR Ø3.5 SELF-TAP L26 TI| CORTSCR Ø3.5 SELF-TAP L45 TI| LCP ONE-THIRD TUBULAR PLATE 3.5, 6 HOLES