BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI OBA PLATE ANCHOR DOMED DESIGN 4 HOLES

    MDR report key: 4803357 · Received May 28, 2015

    Report

    Report Number
    2520274-2015-14090
    Event Type
    Injury
    Date Received
    May 28, 2015
    Report Date
    May 5, 2015
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE WHEN THE SUBJECT PLATE BROKE IS UNCLEAR. THE PLATE MAY HAVE BROKEN ON (B)(6) 2014 THE SAME DATE THE FIRST REVISION PROCEDURE WAS PERFORMED, BUT ADDITIONAL CLARIFICATION WAS NOT PROVIDED. (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. 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

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT:ARTICLE: 04.500.013 LOT. 7432188, OUR INVESTIGATION OF THE RETURNED PLATE HAS SHOWN, THAT A PART IS BROKEN OFF. THE PLATE SHOWS SCRATCHES AT THE WHOLE PART. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO THIS BREAKAGE, IT IS LIKELY THAT A MECHANICAL OVERLOAD SITUATION HAS LED TO THIS DAMAGE, OR THE IMPLANT WAS BENT IN DIFFERENT DIRECTIONS. THE DEVICE HISTORY RECORD WAS RESEARCHED, NO ABNORMAL FINDINGS WERE IDENTIFIED. THERE WERE NO ISSUES DURING THE MANUFACTURING OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. UNKNOWN SCREWS: THE VISUAL INVESTIGATION OF THE SCREWS HAS SHOWN SOME SMALL SCRATCHES AT THE HEAD. NO OTHER DAMAGES ARE VISIBLE. 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

    RETURNED DATE PREVIOUSLY OMITTED FROM FOLLOW-UP REPORT. 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 RETURNED TO MANUFACTURER. LOT NUMBER REPORTED. 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 HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: DATE OF MANUFACTURE: 09/17/2013. EXPIRATION DATE: N/A, A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 7432188 OF TI OBA PLATE ANCHOR, DOMED DESIGN 4 HOLES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NONCONFORMANCES NOTED. A SINGLE PIECE WAS REWORKED AT OPERATION 30 (ANODIZE) 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 WAS CONDUCTED FOR THE RAW MATERIAL LOT 7126842. THE LOT WAS ACCEPTED WITH NCR 1065073 FOR CHARACTERISTICS DETERMINED ACCEPTABLE FOR USE. THE NCR WAS WRITTEN FOR COSMETIC ISSUES AND ROUGH SURFACE FINISH AND THE RELEASED MATERIAL WAS DISPOSITIONED UAI AS ALL PRODUCT IS INSPECTED FOR COSMETIC CONFORMANCE PRIOR TO RELEASE. DEVIATION ED357 WAS ALSO APPLIED TO THIS RAW MATERIAL LOT. ED357 WAS WRITTEN TO ALLOW THE USE OF SMALLER TITANIUM BILLETS TO MEET MAXIMUM OUT OF FLAT CONDITIONS THAT MAY BE PRESENT IN LARGER BILLET SIZES. THERE ARE NO INDICATIONS OF ANY POTENTIAL ISSUES THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. MANUFACTURING SITE REPORTED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTED AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH SIX BONE ANCHOR PLATES AND AN UNKNOWN QUANTITY OF 6 MM SELF-DRILLING MATRIX MIDFACE SCREWS ON (B)(6) 2014. ON AN UNKNOWN DATE ONE OF THE PLATES, LOCATED IN THE MANDIBLE, BROKE. IT WAS REPORTED THAT THE HEAD OF THE PLATE HAD BROKEN OFF. ELASTIC HAD BEEN USED ONLY FOR A FEW DAYS. ON (B)(6) 2014, A REVISION PROCEDURE WAS PERFORMED TO ADDRESS THE BROKEN PLATE HEAD SO TREATMENT COULD BE CONTINUED WITHOUT REMOVING THE PLATE. THE SURGEON CREATED A TEMPORARY SOLUTION BY MILLING THE PLATE TO MAKE A HOOK AND ATTACHED ETCHED PLASTIC DENTAL MATERIAL TO THE BROKEN END OF THE PLATE. THIS ENABLED TREATMENT, WHICH INVOLVES PULLING/DRAWING THE PLATE BY ELASTIC, TO CONTINUE. THE PLASTIC ATTACHMENT HAD BEEN CHANGED TWICE DURING (B)(6) 2014 DUE TO FAILURE. DURING A FOLLOW UP EXAM ON (B)(6) 2014, THE PROVISIONAL ATTACHMENT WAS DETERMINED TO BE WORKING FINE. THE OTHER FIVE BONE ANCHOR PLATES ARE REPORTED TO BE WORKING CORRECTLY WITH NO BREAKAGE REPORTED. A RELATED COMPLAINT ((B)(4)¿REPORTED SEPARATELY) ADDRESSES THE BROKEN PLATE AND THE INITIAL PROCEDURES PERFORMED TO ADDRESS IT. A REVISION/EXPLANT SURGERY WAS PERFORMED ON APRIL 30, 2015 TO REMOVE THE BROKEN ANCHOR PLATE AND ASSOCIATED SCREWS. A NEW ANCHOR PLATE WAS IMPLANTED DURING THIS SURGERY. THE REVISION/EXPLANT SURGERY IS ADDRESSED IN THIS COMPLAINT. THIS REPORT IS 1 OF 2 FOR (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345801 TI OBA PLATE ANCHOR DOMED DESIGN 4 HOLES IMPLANT, ENDOSSEOUS, ORTHODONTIC OAT SYNTHES ELMIRA 7432188

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention