BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALVEOLAR DISTRACTOR DISTRACTION-L 8 TI

    MDR report key: 3546209 · Received January 2, 2014

    Report

    Report Number
    8030965-2013-05614
    Event Type
    Injury
    Date Received
    January 2, 2014
    Date of Event
    July 4, 2013
    Report Date
    August 10, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MQN
    PMA / PMN Number
    K043555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DHR REVIEW WAS NOT POSSIBLE. PART/LOT COMBINATION UNKNOWN AT SYNTHES (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT EVALUATION CONCLUSION: NO DAMAGE ON THE DISTRACTOR OR THE BONE SCREWS COULD BE DETECTED. THE DISTRACTOR IS WORKING WELL. WE CANNOT SEE ANY RELATION TO THE REPORTED RESULT BECAUSE THE DEVICE DOES NOT SHOW ANY ERROR. SINCE IT WAS A BILATERAL SURGERY, WE ASSUME THAT A WRONG DEVICE HAS BEEN RETURNED. EXACT DATE DEVICE BROKE IS UNKNOWN. CORRECTED LOT #:3003496. HEALTH PROFESSIONAL.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE PATIENT HAD A BILATERAL ALVEOLAR MANDIBLE. THE SURGERY OCCURRED WITHOUT INTERRUPTION AND THE ACTIVATION DISTRACTOR PROTOCOL WAS IMPLEMENTED ACCORDING TO SYNTHES INSTRUCTION. AFTER 3 MONTHS, OBSERVATIONS WERE MADE RESULTING IN RADIOGRAPHY CONTROL. AFTER 3 WEEKS OF SURGERY, THE SCREWS BROKE. THE PATIENT WAS IMPACTED AND NEEDED SURGICAL INTERVENTION TO REPLACE THE IMPLANT. THERE WAS NO DELAY. THE BREAK OF THE IMPLANT WAS DURING RECUPERATION. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705 ALVEOLAR DISTRACTOR DISTRACTION-L 8 TI MQN SYNTHES GMBH 3003496

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention