BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM TI CURVED BROAD LCP® PLATE 16 HOLES/300MM

    MDR report key: 6190749 · Received December 20, 2016

    Report

    Report Number
    3009450884-2016-10122
    Event Type
    Injury
    Date Received
    December 20, 2016
    Report Date
    November 29, 2016
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HRS
    UDI-DI
    07611819290693
    PMA / PMN Number
    K092609
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES, THERAPY DATE IS MAY 2016 (EXACT DATE IS UNKNOWN). THE DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    (B)(4). (B)(6). ORIGINAL IMPLANT DATE IS (B)(6) 2016, EXACT DATE IS UNKNOWN. DEVICE EXPLANT DATE IS (B)(6) 2016, EXACT DATE IS UNKNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PART # 426.662, LOT # 9243455: MANUFACTURING LOCATION: (B)(6). MANUFACTURING DATE: (B)(6) 2014: NO NON-CONFORMANCE REPORTS (NCRS) 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    (B)(6). A MANUFACTURING EVALUATION WAS COMPLETED: THE PRODUCT WAS RETURNED IN A PACKAGING DIFFERENT FROM THE ORIGINAL PACKAGING. THE LASER MARKING IS READABLE. TRACES OF USE AND DAMAGED THREADED HOLE ARE VISIBLE. THE PLATE IS BROKEN AT THE SEVENTH HOLE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE AFFECTED LOT, NO ABNORMALITIES OR DEVIATIONS, NO REWORK WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. ALL DIMENSIONS RELEVANT FOR THE FUNCTION OF THE PRODUCT WERE MEASURED, AND FULFILL THE SPECIFICATIONS. THE RAW MATERIAL CERTIFICATES WERE CHECKED AND IT WAS FOUND THAT ALL USED RAW MATERIAL FULFILLED THE SPECIFICATIONS. BASED ON THIS THE COMPLAINT IS RATED AS CONFIRMED BUT NOT VALID FROM THE POINT OF VIEW OF THE MANUFACTURING SITE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS OCCURRENCE. NO PRODUCT FAULT COULD BE DETECTED. A PRODUCT INVESTIGATION WAS COMPLETED ON THE RETURNED CONCOMITANT DEVICES: FIVE (5) ADDITIONAL SCREWS WERE RECEIVED WITH THE PLATE, THE SCREWS ARE IN A GOOD CONDITION AND DO NOT SHOW ANY DAMAGE; ALSO THE SCREWS ARE NOT RESPONSIBLE TO THE BREAKAGE OF THE PLATE. 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

    CONCOMITANT DEVICES REPORTED: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 70MM (PART #413.370-CX, LOT # 8676779, QUANTITY 1), 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 55MM (PART # 413.355-CX, LOT # 9315175, QUANTITY 1), 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 50MM (PART # 413.350, LOT # 2640113, QUANTITY 1), 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 36MM (PART # 413.336-CX, LOT # 9024435, QUANTITY 1), 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 32MM (PART # 413.332-CX, LOT # 9004918, QUANTITY 1).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED THAT THE 4.5MM TITANIUM CURVED BROAD LOCKING COMPRESSION PLATE (LCP) WAS IMPLANTED TO THE PATIENT IN (B)(6) 2016. POST-OPERATIVELY, AFTER 3 MONTHS ON AN UNKNOWN DATE THE PLATE BROKE. REVISION SURGERY WAS PERFORMED IN (B)(6) 2016 (EXACT DATE IS UNKNOWN) TO REMOVE THE BROKEN PLATE. NO FRAGMENTS WERE GENERATED AND NO BROKEN PARTS OF THE PLATE REMAINED IN THE PATIENT. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. REPORTEDLY OTHER MEDICAL INTERVENTIONS WERE NEEDED. THIS IS REPORT 1 OF 1 FOR (B)(4) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839223 4.5MM TI CURVED BROAD LCP® PLATE 16 HOLES/300MM PLATE,FIXATION,BONE HRS SYNTHES GRENCHEN 9243455 07611819290693

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention