BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI OBA PLATE ANCHOR SCREW SELF-DRILLING 6MM

    MDR report key: 4811382 · Received June 2, 2015

    Report

    Report Number
    2520274-2015-14165
    Event Type
    Injury
    Date Received
    June 2, 2015
    Report Date
    May 11, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    OAT
    PMA / PMN Number
    PK093299
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT INFORMATION IS UNKNOWN. EVENT DATE: UNKNOWN. DEVICE IS PLANNED TO BE EXPLANTED ON (B)(6) 2015, BUT HAS NOT BEEN EXPLANTED YET. 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. 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

    AFTER ADDITIONAL INVESTIGATION, IT WAS DETERMINED THAT THIS DEVICE WAS NOT ASSOCIATED WITH THE REPORTED EVENT. THE MEDWATCH REPORTS FOR THIS DEVICE ARE HEREBY RESCINDED. THE PREVIOUS MEDWATCH REPORTS FOR THIS DEVICE WERE SUBMITTED IN ERROR. 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

    A TOTAL OF SEVEN (7) UNKNOWN SCREWS WERE RETURNED. IT IS UNKNOWN AT THIS TIME WHICH SCREWS WERE RECEIVED. A REVISION PROCEDURE TOOK PLACE ON (B)(6) 2015. IT IS UNKNOWN IF THIS IS ONE OF THE EXPLANTED SCREWS. (B)(4). 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 WHEN THE PATIENT CAME IN FOR FOLLOW UP, THE SURGEON NOTED ORTHODONTIC BONE ANCHOR (OBA) PLATE AND SCREW CONSTRUCT IS LOOSE. SURGEON IS PLANNING TO REMOVE IMPLANTS ON (B)(6) 2015 AND REPLACE WITH NEW IMPLANTS. THIS IS REPORT 9 OF 16 FOR (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED AFTER THIS COMPLAINT FILE WAS RE-REVIEWED AND FURTHER CLARIFICATION OF THE DEVICES INVOLVED IN THE REPORTED EVENT WERE OBTAINED FROM THE REPORTER ON JULY 16, 2015. ADDITIONAL DEVICES, WHICH WERE NOT RELATED TO THIS COMPLAINT, WERE MISTAKENLY REPORTED WITH THE ACTUAL COMPLAINED DEVICES FOR (B)(4). AFTER ADDITIONAL INVESTIGATION, IT WAS DETERMINED THAT ONLY A QUANTITY OF SIX EACH OF PART NUMBER, 04.500.026.01, WERE ASSOCIATED WITH THE COMPLAINED EVENT AND RECEIVED FOR EVALUATION, NOT TEN AS PREVIOUSLY REPORTED. THE ADDITIONAL FOUR DEVICES WERE REPORTED IN ERROR. THE MEDWATCH REPORTS FOR THIS DEVICE ARE HEREBY RESCINDED.

    Description of Event or Problem · 1

    UPDATE: IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED WITH ORTHODENTIC BONE ANCHORS (OBA). DURING A FOLLOW UP VISIT, THE SURGEON NOTICED THAT TWO (2) OBA PLATES IN MAXILLA WERE BECOMING LOOSE. THE SURGEON BROUGHT THE PATIENT BACK TO HIS OFFICE WHERE HE REMOVED THE HARDWARE IN MAXILLA (TWO PLATES AND SIX SCREWS) AND REPLACED IT WITH NEW OBA PLATES AND SCREWS. THE REVISION PROCEDURE WAS SUCCESSFULLY PERFORMED ON (B)(6) 2015 WITH NO SURGICAL DELAY NOTED. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354419 TI OBA PLATE ANCHOR SCREW SELF-DRILLING 6MM IMPLANT, ENDOSSEOUS, ORTHODONTIC OAT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention