BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCK-L-PL-2 R 5HO TI

    MDR report key: 6311852 · Received February 8, 2017

    Report

    Report Number
    3009450884-2017-10019
    Event Type
    Injury
    Date Received
    February 8, 2017
    Date of Event
    January 16, 2017
    Report Date
    January 16, 2017
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HRS
    UDI-DI
    07611819228405
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (B)(4). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART#: 447.265, LOT#: 8921277. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: APR 30, 2014. REVIEW OF THE DEVICE HISTORY RECORDS 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT ON (B)(6) 2015, PATIENT UNDERWENT A PROCEDURE FOR A MAXILLARY HORIZONTAL OSTEOTOMY TO THE JAW DEFORMITY. THE PLANNED REVISION SURGERY FOR PLATE RE-FIXATION WAS PERFORMED ON (B)(6) 2017. DURING THE REVISION SURGERY WHEN TRIED TO REMOVE THE IMPLANTED PLATE, A CRACK ON THE PLATE NEAR THE SCREW HOLE WAS FOUND. THE SCREW WHICH WAS INSERTED TO THE CRACKED SCREW HOLE WAS FIRMLY BURIED INTO THE MAXILLA PIRIFORM APERTURE, SO THE SCREW COULDN'T BE REMOVED FROM THE PATIENT¿S BODY. THE SCREW REMAINED INSIDE THE BODY. THE SURGERY WAS FOR THE PLATE RE-FIXATION WITH (B)(6) PRODUCTS, SO THE BROKEN PLATE WAS REMOVED AND A (B)(6) PRODUCT WAS IMPLANTED. THE SURGEON COMMENTED THAT NO CRACKS OR BREAKAGE WAS FOUND IN THE X-RAY DONE PRIOR TO THE SURGERY. PATIENT OUTCOME WAS NOT REPORTED. SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL PROLONGATION REPORTED. THIS REPORT IS FOR ONE (1) LOCKING PLATE. THIS IS REPORT 1 OF 2 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93786 LOCK-L-PL-2 R 5HO TI PLATE,FIXATION,BONE HRS SYNTHES GRENCHEN 8921277 07611819228405

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention