BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PLATE

    MDR report key: 5986345 · Received September 29, 2016

    Report

    Report Number
    2520274-2016-14728
    Event Type
    Injury
    Date Received
    September 29, 2016
    Report Date
    September 12, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K050608
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR 1 UNKNOWN MATRIX MIDFACE PLATE. UNKNOWN WHICH OF THE FOLLOWING PLATES BROKE: PART # 04.503.385S, LOT # 7797890, UDI # (B)(4), EXPIRATION DATE: UNKNOWN; PART # 04.503.385S, LOT # 3073202, UDI # (B)(4); PART # 04.503.386S, LOT # 7592292, UDI # (B)(4), EXPIRATION DATE: UNKNOWN; PART # 04.503.386S, LOT # 1846290, UDI # (B)(4), EXPIRATION DATE: UNKNOWN. ADDITIONAL CODE USED: DZL. DEVICE IS NOT EXPLANTED. EXPLANT PROCEDURE IS PLANNED IN (B)(6) 2016. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED. (B)(6). (B)(4). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED OF KNOWN ARTICLE AND LOT NUMBER COMBINATIONS: ART: 04.503.385S, LOT: 7797890 DO NOT MATCH. ART: 04.503.394S, LOT: 7797890 COMBINATIONS FOUND. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: FEB 29, 2012, EXPIRY DATE: FEB 01, 2022. ARTICLE STERILIZED BY SUPPLIER (B)(4) LOT # 7797890, ARTICLE 04.503.394 MANUFACTURED IN US LOT # 6869156. ART: 04.503.385S, LOT: 3073202, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 28TH JANUARY 2009, EXPIRY DATE: JAN 01, 2019. ARTICLE STERILIZED BY SUPPLIER (B)(4) LOT # 3073202. ARTICLE 04.503.394 MANUFACTURED IN US LOT # 6008982. ART: 04.503.386S, LOT: 7592292 DO NOT MATCH. ART: 04.503.395S, LOT: 7592292 COMBINATIONS FOUND. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: SEP 16, 2011, EXPIRY DATE: SEP 01, 2021. ARTICLE STERILIZED BY SUPPLIER (B)(4) LOT # 7592292. ARTICLE 04.503.395 MANUFACTURED IN US LOT # 6730718. ART: 04.503.386S, LOT: 1846290 DO NOT MATCH. ART: 04.503.395S, LOT: 1846290 COMBINATIONS FOUND. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: MAR 17, 2008, EXPIRY DATE: MAR 01, 2018. ARTICLE STERILIZED BY SUPPLIER (B)(4) LOT # 1846290. ARTICLE 04.503.395 MANUFACTURED IN US LOT # 5700659. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: FEB 01, 2012, PART #: 04.503.394, LOT#: 6869156 QUANTITY-(B)(4). MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: OCT 24, 2008, PART #: 04.503.394, LOT#: 6008982 QUANTITY-(B)(4). NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DHR SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JUL 28, 2011, PART #: 04.503.395, LOT#: 6730718 QUANTITY-(B)(4). MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JAN 29, 2008,PART #: 04.503.395, LOT#: 5700659 QUANTITY-(B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DHR SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6): IT WAS REPORTED THAT IN (B)(6) 2016, PATIENT UNDERWENT INITIAL SURGERY TO EXTEND MAXILLARY BY OSTEOTOMY USING MAXILLARY DISTRACTOR. ON (B)(6) 2016, PATIENT UNDERWENT REMOVAL SURGERY OF MAXILLARY DISTRACTOR AND MATRIX MIDFACE PLATES WERE USED. REPORTEDLY, IN (B)(6) 2016 THE BREAKAGE OF ONE OF THE REPORTED PLATES IN PATIENT WAS REVEALED. THE REVISION SURGERY TO REMOVE BROKEN PLATE IS PLANNED IN (B)(6) 2016. THIS REPORT IS FOR ONE (1) UNKNOWN MATRIX MIDFACE PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637366 BONE PLATE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention