BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5 VACRVD CONDY PL/8H/195/LT

    MDR report key: 7128868 · Received December 19, 2017

    Report

    Report Number
    8030965-2017-50827
    Event Type
    Injury
    Date Received
    December 19, 2017
    Report Date
    November 23, 2017
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDP
    UDI-DI
    07611819454057
    PMA / PMN Number
    K110354
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 02.124.409, LOT# L020870. MANUFACTURING LOCATION: (B)(4). RELEASE TO WAREHOUSE DATE: JUN 17, 2016. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. LOT L020870 WAS MANUFACTURED FROM BLANK 60067385 LOT 19373: RELEASE TO WAREHOUSE: 22 FEBRUARY 2016. SUPPLIER: (B)(4). THE MATERIAL RELEASE CERTIFICATE WAS REVIEWED; NO NON-CONFORMANCE REPORTS WERE DOCUMENTED. PRODUCT INVESTIGATION WAS COMPLETED. THE RETURNED VA-LCP CONDYLAR PLATE IS BROKEN AT THE LEVEL OF THE VA3 ¿ VA4 HOLE. THE BROKEN PLATE WAS INSPECTED AND ALL MEASURABLE FEATURES PERTINENT TO COMPLAINT CONDITION HAVE BEEN CHECKED. THE MEASUREMENTS HAVE SHOWN THAT THE DIMENSIONS ARE IN ACCORDANCE WITH THE TECHNICAL DRAWING. THE REVIEW OF THE RAW MATERIAL CERTIFICATE INDICATES THAT MATERIAL CONFORMS TO SPECIFICATIONS. CONSIDERING THAT ALL RELEVANT MEASURABLE PRODUCT FEATURES MET SPECIFICATION AND NO VISUAL DEFECTS MANUFACTURING RELATED HAVE BEEN IDENTIFIED ON RETURNED ITEMS, THE CONCLUSION OF THE PRODUCT INVESTIGATION IS THAT THE RETURNED PART IS CONFORMING FROM A MANUFACTURING PERSPECTIVE. THE INVESTIGATION FOUND NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. THE EXACT CAUSE OF FAILURE CANNOT BE DETERMINED; A MATERIAL OR MANUFACTURING RELATED ISSUE CAN BE EXCLUDED. THE REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THIS PLATE WAS MANUFACTURED IN JUNE 2016 ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    DEVICE PRODUCT CODE: HRS, HWC. PATIENT CODE (B)(4) USED TO CAPTURE ADDITIONAL MEDICAL/SURGICAL INTERVENTION REQUIRED. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 FOLLOWS: IT WAS REPORTED THAT A FIXATION OF DISTAL FEMUR FRACTURE WAS PERFORMED ON (B)(6) 2017. POST-OPERATIVE ON AN UNKNOWN DATE, THE PLATE BROKE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 AND A NEW PLATE WAS PLACED. PATIENT AND SURGERY OUTCOME WERE NOT REPORTED. CONCOMITANT REPORTED DEVICES: VARIABLE LOCKING SCREW (PART# 02.231.260, LOT# L230854, QUANTITY 1). VARIABLE LOCKING SCREW (PART# 02.231.265, LOT# L493588, QUANTITY 1). VARIABLE LOCKING SCREW (PART# 02.231.260, LOT# L307185, QUANTITY 1). VARIABLE LOCKING SCREW (PART# 02.231.260, LOT# L428276, QUANTITY 1). VARIABLE LOCKING SCREW (PART# 02.231.250, LOT# L493675, QUANTITY 1). VARIABLE LOCKING SCREW (PART# 02.231.240, LOT# L365073, QUANTITY 2). VARIABLE LOCKING SCREW (PART# 02.231.240, LOT# L489190, QUANTITY 1). VARIABLE LOCKING SCREW (PART# 02.231.238, LOT# L497929, QUANTITY 1). VARIABLE LOCKING SCREW (PART# 02.231.234, LOT# L464097, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909224 4.5 VACRVD CONDY PL/8H/195/LT IMPLANT,FIXATION DEVICE, CONDYLAR PLATE JDP OBERDORF SYNTHES PRODUKTIONS GMBH L020870 07611819454057

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention