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Patient 1
THE PATIENT HAD PROVIDED COPIES OF X-RAYS ON REQUEST, WHICH CONFIRMED LOOSENING OF THE PHALANGEAL COMPONENT IN THE BONE. THE EXACT CAUSE OF REPORTED LUCENCY IS UNKNOWN. AS A PART OF THE INVESTIGATION, INCOMING AND FINAL INSPECTION RECORDS (DHRS) OF THE LOTS IN QUESTION WERE REVIEWED AND NO DISCREPANCIES WERE NOTED. ALL PARTS WERE BUILT TO SPECIFICATION AND NON-CONFORMING PARTS WERE APPROPRIATELY IDENTIFIED AND DISPOSITIONED ACCORDINGLY. THE INSTRUCTIONS FOR USE (IFU) DOCUMENT STATES THAT THIS TYPE OF EVENT CAN OCCUR, AND ALL RISKS ARE ADDRESSED IN THE RISK DOCUMENTATION. A VALID ROOT CAUSE CANNOT BE ESTABLISHED BASED ON AVAILABLE INFORMATION. SEVERAL FACTORS SUCH AS STRESS/ PHYSICAL LOADS ON THE IMPLANTS, VASCULARITY OF THE IMPLANTATION SITE, SURGICAL TECHNIQUES EMPLOYED DURING IMPLANTATION, PATIENT FACTORS (SUCH AS AGE, CURRENT STATE OF THE IMMUNE SYSTEM, BONE QUALITY, AND SENSITIVITY TO DEVICE MATERIALS), AND PATIENT POST-OP COMPLIANCE TO REHABILITATION PROCEDURES ETC. CAN HAVE IMPACT ON THE FUNCTIONAL EFFECTIVENESS OF THE IMPLANTED DEVICES. THE PATIENT WAS ADVISED TO GET A FULL WORK UP DONE BY A SURGEON WHICH MAY HELP IN DETERMINATION OF UNDERLYING CAUSE(S) OF REPORTED LOOSENING. A SECOND MDR WAS FILED FOR THE PATIENT'S OTHER TOEMOTION DEVICE (MDR #: 3004154314-2019-00012). IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, IT WILL BE REVIEWED FOR REPORTABILITY AND SUBMITTED VIA A SUPPLEMENTAL MDR. BELOW IS THE PART AND LOT INFORMATION OF THE PATIENT'S FIRST TOEMOTION IMPLANT. PN: 9P15-S180-A, LOT # 75ID0219, MFG. DATE: 09-2014, EXP. DATE: 09-2019. PN: 9P15-PB01-A, LOT # 75ID0208, MFG. DATE: 11-2014, EXP. DATE: 11-2019.