BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOCKING RECONSTRUCTION PLATE/12 HOLES/96MM

    MDR report key: 5539005 · Received March 31, 2016

    Report

    Report Number
    2530088-2016-10096
    Event Type
    Injury
    Date Received
    March 31, 2016
    Report Date
    March 2, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HRS
    PMA / PMN Number
    PK093772
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL DEVICE PRODUCT CODE IS HWC. DATE OF IMPLANT IS UNKNOWN. THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. 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

    DATE OF MANUFACTURE: JULY 01, 2015. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 9837865 OF TI LOCKING RECONSTRUCTION PLATE WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH 2 PARTS SCRAPPED AND NO 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 6992899 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

    PRODUCT INVESTIGATION SUMMARY: ONE PLATE (PART 449.612 / LOT 9837865) AND SIX SCREWS (PART 497.692 X5 AND PART 497.691 X1) WERE RETURNED FOR INVESTIGATION. THESE IMPLANTS ARE INTENDED FOR USE IN RECONSTRUCTIVE/TRAUMATIC INJURIES OF THE MANDIBLE. THE PLATE WAS RECEIVED IN TWO (2) BROKEN PIECES EACH WITH MARKS CONSISTENT WITH INTRA-OPERATIVE BENDING AND IMPLANTATION. THE CAUSE OF THE PLATE BREAKAGE COULD NOT BE DETERMINED. HOWEVER, IT IS POSSIBLE THAT EXCESSIVE INTRA-OPERATIVE BENDING DURING IMPLANTATION WEAKENED THE PLATE THEREBY CAUSING IT TO FAIL. ALSO, EXCESSIVE STRAIN BY THE PATIENT COULD HAVE LED TO THE BREAKAGE AS WELL. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. THE RELEVANT DRAWINGS WERE REVIEWED WITH NO DRAWING ISSUES OR DISCREPANCIES NOTED. THE DESIGN WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO MANUFACTURING OR DESIGN-RELATED ISSUES WERE NOTED DURING THE INVESTIGATION. AS A NOTE: THE RETURNED SCREWS, WHICH HAD NO ALLEGED MALFUNCTION, WERE RECEIVED WITH EVIDENCE OF COSMETIC WEAR THAT IS CONSISTENT WITH BEING IMPLANTED. NO PRODUCT DESIGN OR MANUFACTURING RELATED ISSUES WERE IDENTIFIED WITH THE RETURNED SCREWS; THEREFORE, A REVIEW TO THE SPECIFIC DESIGN OR MANUFACTURING DOCUMENTATION IS NOT APPLICABLE. 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

    IT WAS REPORTED THAT A BROKEN PLATE WAS DISCOVERED ON AN X-RAY DURING A ROUTINE, POSTOPERATIVE, FOLLOW-UP CLINICAL VISIT ON AN UNKNOWN DATE. THE PATIENT ORIGINALLY HAD A MANDIBLE RECONSTRUCTION SURGERY ON AN UNKNOWN DATE DURING WHICH TIME THE PLATE WAS IMPLANTED. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016 TO REMOVE THE BROKEN PLATE AND IMPLANT A NEW CUSTOM MILLED PLATE. NO ISSUES OCCURRED DURING REVISION SURGERY. THERE WAS NO DELAY AND THE SURGEON WAS SATISFIED WITH THE PATIENT'S OUTCOME. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193147 TI LOCKING RECONSTRUCTION PLATE/12 HOLES/96MM PLATE, FIXATION, BONE HRS SYNTHES BRANDYWINE 9837865

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention