BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI OBA PLATE ANCHOR DOMED DESIGN 4 HOLES

    MDR report key: 4553116 · Received February 27, 2015

    Report

    Report Number
    2520274-2015-11033
    Event Type
    Malfunction
    Date Received
    February 27, 2015
    Report Date
    February 4, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    OAT
    PMA / PMN Number
    PK093299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE BROKE DURING INSERTION; DEVICE WAS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REPORT WAS INITIALLY SUBMITTED ON (B)(4) 2015 BUT THE FDA SITE WAS DOWN. ADVISED BY FDA ON (B)(4) 2015 TO RESUBMIT MEDWATCH. 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 DURING AN ORTHODONTIC BONE ANCHOR CASE, ONE OF THE BONE ANCHOR PLATES BROKE DURING CLOSING. IT IS NOT REVISION SURGERY. THERE WAS NO DELAY IN THE SURGERY. NO FRAGMENT WAS GENERATED DUE TO BREAKAGE OF BONE ANCHOR DURING SURGERY AND NO ADDITIONAL INTERVENTION WAS REQUIRED. PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139159 TI OBA PLATE ANCHOR DOMED DESIGN 4 HOLES IMPLANT, ENDOSSEOUS, ORTHODONTIC OAT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1