BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTIS SCREW

    MDR report key: 8503749 · Received April 11, 2019

    Report

    Report Number
    3004549189-2019-00027
    Event Type
    Injury
    Date Received
    April 11, 2019
    Report Date
    September 20, 2019
    Manufacturer
    S.B.M. SAS
    Product Code
    HWC
    PMA / PMN Number
    K120818
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO CLINICAL CONSEQUENCES FOR THE PATIENT. WE ARE WAITING FOR THE DEVICE FOR EXPERTISE.

    Additional Manufacturer Narrative · 1

    NO CLINICAL CONSEQUENCES FOR THE PATIENT. WE ARE WAITING FOR THE DEVICE FOR EXPERTISE. FOLLOW UP #1 : AFTER RECEPTION OF EXPLANTED DEVICES, THE BROKEN SCREW IS OTIS SCREW L65MM - REF. EVO9066065 - LOT 142847 - PROD DATE: SEP 30, 2014 - EXP DATE: SEP 30, 2019. PRODUCTION RECORD CONFORMS TO SPECIFICATIONS. RESULT OF THE EXPERTISE: THE BREAKAGE MAY HAVE OCCURRED IN TORSION WHEN LOOSENING THE SCREW (IF THE HEALING OF THE BONE FILLED THE SELF-TAPPING PORTION OF THE SCREWS, IT COULD MAKE LOOSENING VERY DIFFICULT). THIS TYPE OF INCIDENT REMAINS VERY ISOLATED. NO CORRECTIVE ACTION IMPLEMENTED. THIS FILE IS NOW CLOSED.

    Description of Event or Problem · 1

    (B)(4). "INCIDENTAL DISCOVERY AT ABLATION OF A SUPERIOR POSTERIOR SCREW RUPTURE OF AN OTIS PLATE". "BROKEN PART LEFT IN PLACE". DATE OF EVENT IS UNKNOWN. UP TO DATE, WE DO NOT KNOW WHICH SCREW HAS BROKEN. LIST OF DEVICES USED : OTIS-C PLUS PLATE - REF. EVO9067722 - LOT 144285 - PROD. DATE : JAN. 25TH 2015 - EXP. DATE : JAN. 25TH 2020, OTIS SCREW L65MM - REF. EVO9066065 - LOT 142847 - PROD. DATE : SEP. 30TH 2014 - EXP. DATE : SEP. 30TH 2019, OTIS SCREW L60MM - REF. EVO9066060 - LOT 144246 - PROD. DATE : JAN. 21ST 2015 - EXP. DATE : JAN. 21ST 2020, OTIS SCREW L50MM - REF. EVO9066050 - LOT 144282 - PROD. DATE : JAN. 25TH 2015 - EXP. DATE : JAN. 25TH 2020, OTIS SCREW L45MM - REF. EVO9066045 - LOT 152061 - PROD. DATE : JUL. 23TH 2015 - EXP. DATE : JUL. 23TH 2020.

    Description of Event or Problem · 1

    (B)(4). "INCIDENTAL DISCOVERY AT ABLATION OF A SUPERIOR POSTERIOR SCREW RUPTURE OF AN OTIS PLATE". "BROKEN PART LEFT IN PLACE". DATE OF EVENT IS UNKNOWN. UP TO DATE, WE DO NOT KNOW WHICH SCREW HAS BROKEN. LIST OF DEVICES USED: OTIS-C PLUS PLATE - REF. EVO9067722 - LOT 144285 - PROD DATE: JAN 25, 2015 - EXP DATE: JAN 25, 2020. OTIS SCREW L65MM - REF. EVO9066065 - LOT 142847 - PROD DATE: SEP 30, 2014 - EXP DATE: SEP 30, 2019. OTIS SCREW L60MM - REF. EVO9066060 - LOT 144246 - PROD DATE: JAN 21, 2015 - EXP DATE: JAN 21, 2020. OTIS SCREW L50MM - REF. EVO9066050 - LOT 144282 - PROD DATE: JAN. 25, 2015 - EXP DATE: JAN 25, 2020. OTIS SCREW L45MM - REF. EVO9066045 - LOT 152061 - PROD DATE: JUL. 23, 2015 - EXP DATE: JUL. 23, 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296313 OTIS SCREW METALLIC SCREW FOR PLATE FIXATION HWC S.B.M. SAS EVO9066065 142847

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other