BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 16MM

    MDR report key: 4371952 · Received December 30, 2014

    Report

    Report Number
    2520274-2014-15653
    Event Type
    Injury
    Date Received
    December 30, 2014
    Report Date
    December 2, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    PK063790
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE SCREW RECEIVED IS IN GOOD OVERALL CONDITION, WITH ONLY NEGLIGIBLE WEAR IN AREAS WHERE THEY WERE CONTACTED BY INSTRUMENTS DURING THE INSERTION OR REMOVAL OF THE PLATE. ONE PATIENT SPECIFIC PLATE FOR MANDIBLE (PART NUMBER SD480.110; LOT NUMBER 7801019) AND SIX SCREWS (04.503.640.01 (QUANTITY 3), 04.503.646.01 (QUANTITY 1), 04.503.648.01 (QUANTITY 2); ALL SCREW LOT NUMBERS UNKNOWN) WERE RETURNED. UPON RECEIPT OF THESE DEVICES, THEY WERE SEEN TO BE IN GOOD OVERALL CONDITION, WITH ONLY SLIGHT SIGNS OF WEAR IN AREAS WHERE THEY WERE CONTACTED BY INSTRUMENTS DURING THE INSERTION OR REMOVAL OF THE PLATE. THE SURGEON NOTED THE PLATE WAS APPROPRIATELY ADAPTED AT BOTH INSERTION AND REMOVAL OF THE PLATE, AND THAT ALL SCREWS WERE SECURED WITHOUT COMPLICATION. EXACT PLACEMENT OF THE SCREWS COULD NOT BE DETERMINED DUE TO A LACK OF X-RAY INFORMATION. THE ROOT CAUSE OF THIS COMPLAINT IS INDETERMINATE, BUT IS LIKELY ATTRIBUTED TO THE CONDITION AND THE VARIABLES ASSOCIATED WITH THE HEALING OF THE PATIENT. THIS COMPLAINT IS UNCONFIRMED AS NEITHER PICTURES NOR X-RAYS WERE PROVIDED PRIOR TO THE DEVICE REMOVAL; THOUGH ROOT CAUSE IS INDETERMINATE, THE DCRM ADEQUATELY COVERS THE RISK OF IMPLANT MIGRATION THROUGH SKIN. 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

    (B)(4).DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSISIF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4): THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.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 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 USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PREFORMED, MILLED PATIENT-SPECIFIC MANDIBLE PLATE WAS REMOVED BECAUSE THE SOFT TISSUE OF THE MANDIBLE RESECTED AND THE PLATE CAME THROUGH THE SOFT TISSUE. PRIOR TO THE IMPLANTATION SURGERY THAT OCCURRED ON (B)(6) 2014, THE PATIENT RECEIVED RADIATION TREATMENT FOR THE TUMOR. POSTOPERATIVELY, THE PATIENT RECEIVED OXYGEN THERAPY. THE PLATE WAS EASILY REMOVED FROM THE PATIENT ON (B)(6) 2014. THERE WERE NO FRAGMENTS. THIS IS REPORT 7 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857417 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 16MM BONE PLATE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention