BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - PSI IMPLANTS

    MDR report key: 12174087 · Received July 15, 2021

    Report

    Report Number
    2939274-2021-04116
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Report Date
    June 15, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    GXN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H6: INVESTIGATION SUMMARY: THE DEVICE WAS NOT RECEIVED. A MANUFACTURING INVESTIGATION WAS CONDUCTED BY LEGAL MANUFACTURER: MATERIALISE BASED ON THE AVAILABLE PRODUCT AND PATIENT INFORMATION. DESIGN REVIEW: DURING THE INVESTIGATION MECHANICAL INTEGRITY AND DESIGN OF THE GUIDE, THE PLANNING, SPLINT DESIGN AND PRODUCTION STEP WERE INVESTIGATE AS THE ISSUE WAS RELATED TO THE FIT. NO ISSUES WERE FOUND WITH THE DESIGN OF THE GUIDE. THE SPLINT MIGHT BE WEAKER IN THE AREA WITH LARGER HOLE REPRESENTATION BUT THIS CANNOT BE AVOIDED DUE TO INTERSECTION BETWEEN DENTITION. THIS IS APPROVED BY SURGEON AS IT MEET THE OCCLUSION AND PLANNING AS DETERMINED BY SURGEON. THE THICKNESS ANALYSIS ALSO MEET ALL SPECIFICATION. ADDITIONALLY, THE DUPLICATE SPLINT WITH EXACT SAME DESIGN DID NOT HAVE THE FIT ISSUE AND NOT BREAK. IT IS UNLIKELY THAT DESIGN ISSUE ON THE SPLINT COULD HAVE CAUSE THE COMPLAIN CONDITION. DURING QI, A GO/NO GO GAGE IS USED ON A PCP PART OF THAT BUILD TO CHECK IF THE GEOMETRICAL PROPERTIES OF THE PARTS ON THAT BUILD MEET SPECIFICATIONS. IT WAS CONFIRMED THAT THE PART MET SPECIFICATIONS AND THAT ALL POST-PROCESSING WAS COMPLETED CORRECTLY. THERE IS A POSSIBILITY THAT SPLINT COULD HAVE DEFORMED DURING POST-PROCESSING OR SHIPMENT BUT THIS CANNOT BE CONFIRMED. ALSO, THE SPLINT GOT BROKEN WHILE HANDLING INTRAOPERATIVELY BY SURGEON WHILE TRYING TO FIX THE FIT ISSUE. CONCLUSION: THE COMPLAINT CONDITION CAN BE CONFIRMED FOR THE PATIENT SPECIFIC SPLINT, ORTHOGNATHIC(P/N: SD900.106 & LOT #: MU21-CUX-ZIC). HOWEVER, THE COMPLAINT CONDITION CANNOT BE TRACED TO DEVICE DESIGN OR PRODUCTION BASED ON INVESTIGATION. THE ROOT CAUSE OF THE ISSUE CANNOT BE DETERMINED BASED ON THE INVESTIGATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION AS ITS UNCONFIRMED. NO MANUFACTURING ISSUES WERE NOTED DURING INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. H3, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER: SD900.106, LOT #: MU21-CUX-ZIC, DHR WAS PERFORMED BY MATERIALISE AND THE DEVICE MET SPECIFICATIONS. THERE WERE NO NC IDENTIFIED IN THE DHR OF THIS CASE. 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

    PRODUCT COMPLAINT # (B)(4). PMA/510K: THIS REPORT IS FOR AN UNK - PSI IMPLANTS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J SALES REPRESENTATIVE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, ONE OF THE FINAL SPLINTS DID NOT FIT THE POST-OP MODEL VERY WELL WHILE THE SURGEON WAS CHECKING THEM THE DAY BEFORE THE SURGERY. SINCE THERE WAS A BACKUP SPLINT THAT FIT WELL, AND ALSO ANOTHER FINAL SPLINT DESIGN, IT WAS FINE TO PROCEED WITH THE SURGERY, WHICH WENT VERY WELL. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) UNK - PSI IMPLANTS. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074069 UNK - PSI IMPLANTS PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE GXN WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1