BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXMANDIBLE SUBCONDYLAR PLATE LAMBDA/LEFT/1.0MM THICK

    MDR report key: 6904622 · Received September 29, 2017

    Report

    Report Number
    3000270450-2017-10344
    Event Type
    Injury
    Date Received
    September 29, 2017
    Date of Event
    August 30, 2017
    Report Date
    September 7, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JEY
    PMA / PMN Number
    K091233
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT: UNKNOWN. (B)(4). DEVICE NOT EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4) - THE IMPLANTED PLATE WAS BROKEN UNDER X-RAY WHEN THE PATIENT VISITED THE HOSPITAL ON (B)(6) 2017, THE SURGEON DECIDED TO KEEP THE BROKEN PLATE IN THE PATIENT'S BODY SINCE THE PATIENT'S BONE WAS REDUCED AND COALESCED. THE PATIENT IS UNDER MONITORING. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART #04.503.831S / LOT #8921830; PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4); SUPPLIER: (B)(4); MANUFACTURING DATE: 08.APR.2014 EXPIRY DATE: 01.MAR.2024. NO 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 04.503.831 / 7603333 WAS MANUFACTURED IN US. NON-STERILE 04.503.831 / 7603333 WAS MANUFACTURED IN US. PART MFG DATE: 19-FEB-2014. PART EXP. DATE: N/A . MANUFACTURING LOCATION: DEPUY SYNTHES ¿ ELMIRA. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT# 7603333 OF TI MATRIXMANDIBLE SUBCONDYLAR PLATE LAMBDA/LEFT/1.0MM THICK WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMMENTS: A REVIEW OF THE BILLET MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT (7545619) MET ALL SPECIFICATIONS. INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    (B)(4). 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 ON AN EVENT IN (B)(6) AS FOLLOWS: THE REPORTED PLATE WAS IMPLANTED TO A PATIENT¿S MANDIBULAR JOINT ON (B)(6) 2014. IT WAS REPORTED THAT THE SURGEON FOUND THE IMPLANTED PLATE WAS BROKEN UNDER X-RAY WHEN THE PATIENT VISITED THE HOSPITAL ON (B)(6) 2017. THEN, THE SURGEON CHECKED THE PATIENT¿S HISTORICAL MEDICAL RECORD AND FOUND THAT THE PLATE HAD BEEN BROKEN AFTER 6 MONTH FROM THE IMPLANTATION SURGERY. THE SURGEON JUDGED TO KEEP THE BROKEN PLATE REMAINED IN THE PATIENT'S BODY SINCE THE PATIENT'S BONE WAS REDUCED AND COALESCED, ALSO THERE WAS NO LOOSENING OF THE SCREW WHICH FASTENING THE PLATE IN QUESTION. THE PATIENT IS UNDER MONITORING. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT DEVICE: 1X UNK SCREW. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684605 TI MATRIXMANDIBLE SUBCONDYLAR PLATE LAMBDA/LEFT/1.0MM THICK BONE PLATE JEY SYNTHES SELZACH 8921830

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 1X UNK SCREW