BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDIATRIC LCP HIP PLATE 3.5MM/140°/3 HOLES-STERILE

    MDR report key: 7035903 · Received November 15, 2017

    Report

    Report Number
    3006126083-2017-10054
    Event Type
    Injury
    Date Received
    November 15, 2017
    Report Date
    October 23, 2017
    Manufacturer
    SYNTHES RARON
    Product Code
    HRS
    PMA / PMN Number
    K112085
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. CONCOMITANT PARTS & PART NUMBERS ADDED TO COMPLAINT, 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

    PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. THE INVESTIGATION SUMMARY INDICATES THAT: A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. PLATE PART# 02.108.316S / LOT# 9799890 THE RETURNED PLATE SHOWS WEAR CONSISTENT WITH IMPLANTATION AND EXPLANTATION. THE THREADFORM ON THE LOCKING HOLES SHOW EVIDENCE OF USE WITH LOCKING SCREWS. THE PLATE IS NOT BROKEN AND VISUAL INSPECTION UNDER 5X MAGNIFICATION REVEALED THAT THE PLATE IS NOT BENT OR CRACKED EITHER. THE MATERIAL AND RELEVANT MATERIAL PROPERTIES WERE DETERMINED TO BE CONFORMING AT THE TIME OF MANUFACTURE BASED ON REVIEW OF THE DHR. A DIMENSIONAL INSPECTION WAS NOT PERFORMED AT CQ BECAUSE THE PLATE IS NOT BROKEN AND BECAUSE OF THE POST MANUFACTURING WEAR (THREAD WEAR CONSISTENT WITH IMPLANTATION AND EXPLANTATION). NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. ADDITIONALLY, THE CALCULATED OCCURRENCE RATE IS ACCEPTABLE WITH THE APPLICABLE DESIGN AND CLINICAL RISK MANAGEMENT OCCURRENCE RATE. 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

    PATIENT IDENTIFIER NOT AVAILABLE FOR REPORTING. (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW WAS COMPLETED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 12 FEB 2016 EXPIRY DATE: 01 FEB 2026. NO 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. 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: DEC 7, 2017, MATERIAL UPDATE ON 08.DEC. 2017: THE CONCOMITANT MATERIAL RECEIVED; PART AND LOT NUMBER LOCATED: 2X 213.050S / 9536383 LOCKSCR Ø3.5, 1X 413.324 / 9062594 LOCKSCR Ø5K, 1X 247.346-US / 9926366 LCP 2 STR 6HO, 1X 213.020 / 9608785 LOCKSCR Ø3.5, 1X 213.020S / L287488 LOCKSCR Ø3.5. UPDATE: DEC.11, 2017 IN AGREEMENT WITH THE INVESTIGATOR: ACCORDING TO THE ENCLOSED X-RAY PICTURES, IT WAS FOUND THAT THE 2X LOCKSCR Ø3.5 ARE BACKED OUT, AND THE PLATE LCP PAED-HIPPL 3.5 140° STRAIG W/19 L70 IS NOT BROKEN. IN ADDITION, PART NUMBER OF CONCOMITANT PARTS CHANGED, PATIENT INFORMATION ADDED. CONCOMITANT PARTS: 1X 204.820S/ 9926368 CORTEX SCREW , 1X 204.830S/ 9602594 CORTEX SCREW , 1X 213.020S / L287488 LOCKSCR Ø3.5, 1X 213.020S / 9608785 LOCKSCR Ø3.5. THIS REPORT IS 1 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT UNDERWENT A DEROTATION VARISATION HIP OSTEOTOMY (DVO) ON (B)(6) 2017. POST-OPERATIVE RADIOGRAPHS DETECTED THE PLATE HAD BROKEN OUT OF THE BONE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 FOR A PROXIMAL FEMUR RESECTION. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT REQUIRED ADDITIONAL HOSPITALIZATION FOR SEVEN (7) DAYS DUE TO THE RESECTION PROCEDURE. CONCOMITANT DEVICES REPORTED: 3.5MM CORTEX SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 2), 3.5MM LCP SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 4). THIS REPORT IS FOR ONE (1) PEDIATRIC LCP HIP PLATE 3.5MM 140 DEGREE 3 HOLES. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812402 PEDIATRIC LCP HIP PLATE 3.5MM/140°/3 HOLES-STERILE PLATE, FIXATION, BONE HRS SYNTHES RARON 9799890

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention