BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.3MM CURVILINEAR DISTRACTOR R70/LEFT

    MDR report key: 4943297 · Received July 27, 2015

    Report

    Report Number
    2520274-2015-15031
    Event Type
    Injury
    Date Received
    July 27, 2015
    Report Date
    July 14, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    MQN
    PMA / PMN Number
    PK121502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTABILITY CHANGED TO ADVERSE EVENT. REPORTABILITY CHANGED TO SERIOUS INJURY. 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

    PATIENT WEIGHT IS UNKNOWN. DATE OF DISTRACTION DEFICIENCY IS UNKNOWN, BUT WAS DISCOVERED VIA X-RAY FILMS THREE (3) WEEKS POST-OPERATIVE. IT IS UNKNOWN IF THE DEVICES WERE EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL MANDIBLE OSTEOTOMY WITH CURVILINEAR DISTRACTOR APPLICATION ON (B)(6) 2015. THREE (3) WEEKS POSTOPERATIVE, WHEN THE PATIENT RETURNED FOR A FOLLOW-UP VISIT, X-RAY FILMS SHOWED DISTRACTION DEFICIENCY. ONE SIDE HAD STOPPED DISTRACTING ALL TOGETHER AND THE OTHER SIDE WAS LESS DISTRACTED. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATE 08/04/2015: RECEIVED ADDITIONAL INFORMATION FROM SALES CONSULTANT REPORTING THAT THE DISTRACTOR WAS FUNCTIONING, HOWEVER THE PATIENT DEVELOPED AN INFECTION. THE SALES CONSULTANT REPORTED THAT THE SURGEON TOOK THE PATIENT BACK TO THE OR. A C-ARM X-RAY MACHINE WAS USED AND TESTED THE DISTRACTORS, THEY WERE FUNCTIONING AS FAR AS HE COULD TELL. SINCE THE DISTRACTORS SEEMED TO BE WORKING, HE DIDN'T OPEN UP THE INCISION. THE SURGEON DID NOTICE THAT THE LEFT SIDE HAD DEVELOPED AN INFECTION AND HE WASHED IT OUT SUPERFICIALLY. HE CLOSED BACK DOWN THE DISTRACTORS AND IS PLANNING ON RESUMING DISTRACTION AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487298 1.3MM CURVILINEAR DISTRACTOR R70/LEFT MANDIBLE DISTRACTION DEVICES MQN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention