BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTHESIS, RIB REPLACEMENT

    MDR report key: 6070432 · Received November 1, 2016

    Report

    Report Number
    2520274-2016-15140
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Report Date
    October 7, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    MDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. THIS REPORT IS FOR ONE, UNKNOWN VEPTR RIB HOOK. PART AND LOT NUMBERS WERE NOT AVAILABLE FOR REPORTING. OTHER NUMBER¿UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (THERAPY DATE): UNKNOWN. THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. REPORTING FACILITY PHONE NUMBER IS (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DATE OF MANUFACTURE IS UNKNOWN. 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 (B)(6) REPORTED THE FOLLOWING EVENT: IT WAS REPORTED THAT THERE WAS POSTOPERATIVE MIGRATION OF THE MEDIAL PROXIMAL RIB HOOK. THE INITIAL VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. ON (B)(6) 2016, A PLANNED REVISION SURGERY AND INITIAL INSERTION WAS PERFORMED ON THE PATIENT TO EXPLANT ONE (1) RIB HOOK, ONE (1) RIB CAP AND TWO (2) DISTRACTION LOCKING CAPS. IT WAS REPORTED THAT RIB CAP AND TWO DISTRACTION LOCKING CAPS WERE NOT SEPARATED FROM THE RIB HOOK. THE ORIGINAL TWO (2) 220 MM DISTAL AND PROXIMAL RODS AND ONE (1) LAMINA HOOK REMAINED IMPLANTED IN PATIENT. PATIENT WAS REVISED WITH A NEW RIB HOOK, AND TO STABILIZE THE REVISED IMPLANTS, A TRANSVERSE RIB HOOK AND BAR WERE ATTACHED AND WERE SUCCESSFULLY IMPLANTED. IN ADDITION, INITIAL INSERTION OF THE LATERAL RIB HOOKS AND VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR II) RODS WERE IMPLANTED WITHOUT ANY PROBLEMS. THE PROCEDURE WAS PROLONGED BY FIFTEEN (15) MINUTES, DUE TO INTRA-OPERATIVE MALFUNCTION OF THE RIB HOOK (ADDRESSED IN RELATED COMPLAINT (B)(4)). THE PATIENT WAS REPORTED AS STABLE AFTER THE PROCEDURE. CONCOMITANT DEVICES REPORTED: PART: UNKNOWN (220 MM) DISTAL AND PROXIMAL RODS, LOT# UNKNOWN, QUANTITY (2), PART: UNKNOWN LAMINA HOOK, LOT# UNKNOWN, QUANTITY (1), PART: UNKNOWN RIB CAP, LOT# UNKNOWN, QUANTITY (1), PART: UNKNOWN DISTRACTION LOCKING CAPS, LOT# UNKNOWN, QUANTITY (2). THIS REPORT IS FOR ONE, UNKNOWN VEPTR RIB HOOK. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721271 PROSTHESIS, RIB REPLACEMENT MDI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN DISTR LOCKING CAPS, LOT UNKNOWN, QTY (2)| UNKNOWN LAMINA HOOK, LOT UNKNOWN, QTY (1)| UNKNOWN RIB CAP, LOT UNKNOWN, QTY (1)| UNKNOWN RODS, LOT UNK, QTY 2