BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOCKING LOW PROFILE RECON J-PLATE 16 HOLES RIGHT

    MDR report key: 6750967 · Received July 28, 2017

    Report

    Report Number
    3003506883-2017-10145
    Event Type
    Injury
    Date Received
    July 28, 2017
    Report Date
    June 29, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    UDI-DI
    07611819811447
    PMA / PMN Number
    K042377
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DATE INFECTION BEGAN IS NOT KNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    PATIENT¿S BIRTH YEAR REPORTED AS (B)(6), EXACT DATE OF BIRTH IS UNKNOWN. DEVICE EXPIRATION DATE A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 02.100.366S, LOT # 946354. PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 29. APRIL 2015, EXPIRY DATE: 01. APRIL 2025; 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. NON-STERILE 02.100.366 / 7936414 WAS MANUFACTURED IN US, (B)(4); PART #: 02.100.366, LOT#: 7936414 (NON-STERILE) ¿ 3.5MM LOCKING LOW PROFILE RECON J-PLATE 16 HOLES RIGHT, QUANTITY (B)(4), MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 31-MAR-2015: COMPONENT PART 17020 BP82, LOT: 7549882, RAW MATERIAL RECEIVING/ PUTAWAY CHECKLIST MEET REQUIREMENTS. INSPECTION SHEET FOR INSPECTION II & FINAL INSPECTION MEET SPECIFICATION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CORRECTED DATA: CORRECTED REVISION SURGERY DATE. UDI: (B)(4). 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

    FURTHER IT WAS CLARIFIED THAT THE FIRST REVISION SURGERY TOOK PLACE ON (B)(6) 2016, IN WHICH ONLY ONE SCREW WAS EXPLANTED AND EXCHANGED. A SECOND REVISION SURGERY TOOK PLACE ON (B)(6) 2016 IN WHICH ALL IMPLANTS WERE REMOVED AND REPLACED WITH A NEW PLATE AND SCREWS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2016 DUE TO MIGRATED AND LOOSENED SCREWS. DURING THE REVISION SURGERY ALL PRODUCTS WERE REMOVED. IT IS NOT KNOWN IF NEW SYNTHES DEVICES WERE IMPLANTED. AFTER THE REVISION SURGERY THE PATIENT DEVELOPED AN INFECTION. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION SURGERY IS ADDRESSED IN (B)(4). THIS REPORT ADDRESSES THE POST-OPERATIVE INFECTION. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING LOW PROFILE RECON J-PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532050 3.5MM LOCKING LOW PROFILE RECON J-PLATE 16 HOLES RIGHT PLATE, FIXATION, BONE HRS SYNTHES SELZACH 9463541 07611819811447

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention