BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI OBA PLATE ANCHOR DOMED DESIGN 4 HOLES

    MDR report key: 5630166 · Received May 4, 2016

    Report

    Report Number
    2520274-2016-12508
    Event Type
    Injury
    Date Received
    May 4, 2016
    Report Date
    April 18, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    OAT
    PMA / PMN Number
    PK093299
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE PLATE BROKE IS UNKNOWN; REPORTED AS (B)(6) 2015. THIS REPORT IS FOR AN UNKNOWN ORTHODONTIC BONE ANCHOR PLATE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). 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

    DATE OF MANUFACTURE: MARCH 08, 2013. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 7257189 OF TI OBA PLATE ANCHOR DOMED DESIGN 4 HOLES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO SCRAP OR REWORK NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD(S) DETERMINED THE RAW MATERIAL LOT 6195562 MET ALL SPECIFICATIONS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND 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.

    Additional Manufacturer Narrative · 1

    ADDED CONCOMITANT DEVICES BASED UPON INVESTIGATION SUMMARY. PRODUCT INVESTIGATION SUMMARY: ONE (1) ORTHODONT-BONE ANCHOR-PL DOMED DESIGN 4H (PART 04.500.013, LOT 7257189) WAS RECEIVED FOR EVALUATION WITH COMPLAINT CATEGORY "BROKEN: POSTOPERATIVELY." THIS COMPLAINT IS CONFIRMED AS ONLY A PORTION OF THE BROKEN PLATE WAS RECEIVED. THE PLATE SECTION WITH 4 HOLES WAS RETURNED, BUT THE ANCHOR SECTION WAS NOT. IN ADDITION TO BEING SHEARED IN HALF, THE RETURNED PLATE IS BENT IN SEVERAL AREAS. A THICKNESS MEASUREMENT OF 0.78MM WAS ABLE TO BE TAKEN JUST ADJACENT TO THE AREA OF PLATE BREAKAGE USING CALIPERS. PER DRAWING, THE THICKNESS IS TO BE 0.70MM - 0.80MM. THEREFORE, THE PLATE THICKNESS MEASURES WITHIN SPECIFICATIONS. WHETHER THIS COMPLAINT CAN BE REPLICATED IS NOT APPLICABLE AS THE PLATE IS ALREADY BROKEN. FOUR (4) UNKNOWN SCREWS WERE ALSO RECEIVED WITH THIS COMPLAINT RECORD, BUT SHOW NO EVIDENCE OF HAVING CONTRIBUTED TO THE EVENT. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW, AND DRAWING REVIEW WERE PERFORMED FOR THE RETURNED PLATE AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE RELEVANT DRAWING WAS REVIEWED DURING THIS EVALUATION. THE PLATE WAS MADE FROM COMMERCIALLY PURE GRADE 4 TITANIUM AND ANODIZED. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE MANUFACTURER IS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE COMPLAINT CONDITION WAS MOST LIKELY CAUSED BY EXCESSIVE STRAIN BY PATIENT. IT IS NOT LIKELY THAT THE DESIGN OF THE DEVICE CONTRIBUTED TO THIS COMPLAINT. NO NEW, UNIQUE, OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A BONE ANCHOR WAS BROKEN AFTER IT WAS IMPLANTED IN THE PATIENT. THE PLATE WAS INSERTED ON (B)(6) 2013. THE PLATE BROKE IN (B)(6) 2015 WHEN THEY PUT PRESSURE ON IT DURING A TREATMENT. PATIENT AGE IS (B)(6). SHE IS A HEALTHY YOUNG GIRL WHO HAS BEEN TREATED WITH BONE ANCHORS DUE TO ADJUSTMENT OF HER TEETH. WHEN THE PLATE BROKE THEY SWITCHED TO FEATURES ON APPLIANCES ON THE TEETH INSTEAD OF BONE. THEY HAD TO CHANGE THE TREATMENT. THE BROKEN PLATE WAS LEFT IN PLACE UNTIL PLATES FROM THE OTHER SIDE WERE REMOVED. BONE ANCHORS AND ALL OTHER PARTS WERE REMOVED ON (B)(6) 2016. THIS REPORT IS FOR AN UNKNOWN ORTHODONTIC BONE ANCHOR PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287622 TI OBA PLATE ANCHOR DOMED DESIGN 4 HOLES IMPLANT, ENDOSSEOUS, ORTHODONTIC OAT SYNTHES ELMIRA 7257189

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention