BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI RIB SLEEVE-SIZE 9 220MM RADIUS

    MDR report key: 6149319 · Received December 6, 2016

    Report

    Report Number
    2530088-2016-10337
    Event Type
    Injury
    Date Received
    December 6, 2016
    Report Date
    November 9, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MDI
    PMA / PMN Number
    K142587
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 497.108, LOT# 7143594. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JAN 13, 2013. COMPONENT 24019 ¿ RAW MATERIAL, LOT NUMBER 6828029. NO NONCONFORMING RECORDS WERE GENERATED DURING PRODUCTION. 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. PRODUCT INVESTIGATION WAS COMPLETED FOR PART# 497.108, LOT# 7143594. THE RETURNED THE EXTENSION BAR IS BROKEN ON ONE SIDE. ON THE SURFACE ARE SOME SCRATCHES VISIBLE (NORMAL WEAR AND TEAR) WHICH HOWEVER DO NOT HAVE AN IMPACT TO THE FUNCTION OF THE IMPLANT. 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

    ADDITIONAL NARRATIVE: PATIENT ID/INITIALS AND WEIGHT ARE UNKNOWN. EVENT DATE: UNKNOWN. CONCOMITANT PRODUCT: IT IS UNKNOWN WHEN EACH OF THE CONCOMITANT DEVICES WERE ADDED TO THE CONSTRUCT. (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT POST-OPERATIVELY A LUMB EXTENSION ROD BROKE. ON (B)(6) 2010, THE PATIENT WHO WAS SUFFERING THORACIC INSUFFICIENCY SYNDROME UNDERWENT AN INITIAL SURGERY WITH VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) SYSTEM. AT THAT TIME, THE FIXATION WAS PERFORMED AT FROM RIGHT RIB TO LUMBER WITH HOOK, AND FROM RIGHT RIB TO RIB. THE PATIENT HAS UNDERGONE AN EXTENSION SURGERY EVERY SIX MONTHS. DURING THE LATEST EXTENSION SURGERY, THE COMPLAINED LUMB EXTENSION ROD WAS NOT EXCHANGED AND IT WAS KEPT USING BECAUSE THE FINAL FIXATION SURGERY IS SCHEDULED IN (B)(6) 2017. ON (B)(6) 2016, THE PATIENT WENT TO A HOSPITAL AND A DOCTOR FOUND THE LUMB EXTENSION ROD WAS BROKEN AND UNHOOKED AT AN EXTENSION PART. ON (B)(6) 2016, THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2016, THE REVISION WAS PERFORMED SUCCESSFULLY. ALL OF THE VEPTR HARDWARE WAS REMOVED AND A NEW VEPTR II WAS IMPLANTED WITHOUT PROBLEM, NO ADDITIONAL PATIENT HARM WAS REPORTED. THE SURGEON COMMENTED THAT THE ISSUE LIKELY OCCURRED BECAUSE THE LUMB EXTENSION ROD IN QUESTION WAS EXTENDED TO THE MAXIMUM, SO IT COULD NOT TOLERATE AN ACTIVE CHILD¿S MOVEMENT. CONCOMITANT DEVICES: CLOSURE F/EXTENSION BAR TAN GOLD (PART 497.125, LOT 9961805 AND 7352384 QUANTITY 2); LOCK F/RIB SUPPORT TAN BLUE (PART 497.128, LOT 6882101, QUANTITY 1); CLOSING ½RING F/RIB SUPPORT TAN GOLD (PART 497.126, LOT 6691726, QUANTITY 1); CRANIAL RIB SUPPORT TAN GOLD (PART 497.057, LOT 7058425, QUANTITY 1); LAM-HOOK LE TAN (PART 497.261, LOT 6114506, QUANTITY 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799236 TI RIB SLEEVE-SIZE 9 220MM RADIUS PROSTHESIS, RIB REPLACEMENT MDI SYNTHES BRANDYWINE 7143594

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention 1 PART 497.057, LOT 7058425, CRANIAL RIB SUPPORT| 1 PART 497.126, LOT 6691726, CLOSING ½RING| 1 PART 497.128, LOT 6882101, LOCK F/RIB SUPPORT| 1 PART 497.261, LOT 6114506, LAM-HOOK LE TAN| 2 PART 497.125, LOT 9961805 AND 7352384, BARS