BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI OBA PLATE ANCHOR DOMED DESIGN 4 HOLES

    MDR report key: 5299457 · Received December 15, 2015

    Report

    Report Number
    2520274-2015-17886
    Event Type
    Injury
    Date Received
    December 15, 2015
    Report Date
    November 24, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    OAT
    PMA / PMN Number
    PK093299
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT MANUFACTURE DATE: NOVEMBER 5, 2014. A REVIEW OF THE PLATE DEVICE HISTORY RECORD (DHR) REVEALED NO COMPLAINT RELATED ANOMALIES. THE (DHR) SHOWS THIS LOT OF TITANIUM OBA PLATE ANCHOR DOMED - 4 HOLE WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING ITS MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION A PRODUCT INVESTIGATION WAS COMPLETED: THE FOLLOWING DEVICE(S) WAS RECEIVED: ANCHOR T-PLATE, 4 HOLE, DOMED HEAD, ORTHODONTIC BONE ANCHOR SYSTEM (PART 04.500.013, LOT 7798054) AND 1.55MM MIDFACE SELF-DRILLING SCREW (PART 04.500.026.01, LOT UNKNOWN, QUANTITY: 3). THE RETURNED DEVICES ARE IN GOOD CONDITION. BOTH RETURNED PLATES HAVE BEEN CONTOURED AND CUT, WITH MINOR COSMETIC DAMAGE WHICH INDICATES THAT THE PLATES WERE ONCE IMPLANTED. THE RETURNED SCREWS ARE IN GOOD CONDITION WITH NO FUNCTIONAL DAMAGE AND ONLY MINOR MARRING AROUND THE HEX DRIVE. DUE TO THE NATURE OF THE COMPLAINT, THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED OR VERIFIED. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS UNCONFIRMED. THE RELEVANT DRAWINGS FOR THE DEVICE(S) WERE REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. PROPER USE AND MAINTENANCE FOR THE DEVICE(S) ARE ADDRESSED IN THE TECHNIQUE GUIDE. THE ROOT CAUSE OF THE COMPLAINT CONDITION IS UNKNOWN. NO MANUFACTURING OR DESIGN ISSUES WERE NOTED DURING THE INVESTIGATION. THE DESIGN DETERMINED TO BE ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UNKNOWN WHEN DEVICE MALFUNCTIONED. (B)(4). DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    LOT NUMBER PROVIDED BY REPORTER. DATE RETURNED TO MANUFACTURER. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGEON PERFORMED A BONE-ANCHORED MAXILLARY PROTRACTION (BAMP) PROCEDURE AND IMPLANTED ORTHODONTIC BONE ANCHOR (OBA) IMPLANTS. THE PATIENT CAME IN FOR FOLLOW-UP APPROXIMATELY ONE MONTH AGO. THE SURGEON NOTICED ONE OF THE OBA IMPLANTS WAS LOOSE. THE SURGEON REMOVED LOOSE HARDWARE ON (B)(6) 2015 AND PUT A NEW PLATE IN. THE PATIENT IS DOING WELL. NO SURGICAL DELAY REPORTED. THIS REPORT IS 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827775 TI OBA PLATE ANCHOR DOMED DESIGN 4 HOLES IMPLANT, ENDOSSEOUS, ORTHODONTIC OAT SYNTHES ELMIRA 7798054

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention