BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10M

    MDR report key: 5227203 · Received November 16, 2015

    Report

    Report Number
    9612488-2015-10575
    Event Type
    Injury
    Date Received
    November 16, 2015
    Report Date
    October 30, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    JEY
    PMA / PMN Number
    PK063790
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). 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 · 1

    PRODUCT INVESTIGATION SUMMARY: THE FOLLOWING DEVICES WERE RECEIVED FOR EVALUATION: PART 04.503.638.01S / LOTS 9273378, 9369363, 9213139, 9273378, 9273378 (X5), PART 04.503.640.01S / LOT 9213139, 9257974 (X2), PART 04.503.642.01S / LOT 9219272 (X1), PART 04.503.644.01S / LOT 9279387 (X1). THE SHAFT AND HEAD THREADS AS WELL AS THE RECESS AND TIP SECTIONS SHOW SLIGHT MARKS OF USE. BASED ON THE SURGICAL TECHNIQUE, THE DEVICE SPECIFIC ADVERSE EVENTS OF LOOSENING, BENDING, OR BREAKAGE OF THE DEVICE CAN OCCUR. THE EXACT CAUSE FOR THE LOOSENING OF THE SCREWS COULD NOT BE DETERMINED. IT IS LIKELY THAT BONE MOVEMENT AND/OR INSUFFICIENT TIGHTENING OF THE SCREWS IN THE PLATE LED TO LOOSENING. NO MANUFACTURING-RELATED FAILURES WERE DETECTED. DEVICE 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 · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT PROVIDED BY REPORTER. UNKNOWN WHEN DEVICE MALFUNCTIONED. NOT EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: 04.503.640.01S / LOT 9257974 MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 24TH NOVEMBER 2014, EXPIRY DATE: 1ST NOVEMBER 2024. NO NCR'S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD (S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    UPDATE: THE COMPLAINANT PART WAS RETURNED, INDICATING THAT A REVISION PROCEDURE WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS INFORMATION.

    Description of Event or Problem · 1

    IT WAS FOUND ON (B)(6) 2015 THAT LOCKING SCREWS IMPLANTED IN THE PATIENT'S MANDIBLE HAVE BEEN LOOSENED. THE PATIENT HAD THE INITIAL SURGERY ON (B)(6) 2015. THIS REPORT IS 7 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755285 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10M BONE PLATE JEY SYNTHES BETTLACH 9257974

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention