BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXRIB UNIVERSAL PLATE 8 HOLES

    MDR report key: 3100407 · Received May 8, 2013

    Report

    Report Number
    2520274-2013-02419
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K081623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CODE: HWC. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. FROM A DESIGN PERSPECTIVE, PATIENT PAIN CAN BE DUE TO MANY FACTORS. IT WAS REPORTED THAT THE PATIENT PAIN WAS DUE TO THREE SCREWS LOOSENING WHICH ALLOWED ONE SIDE OF THE PLATE TO BECOME LOOSE. IT WAS ALSO REPORTED THAT AT THE TIME OF REMOVAL THE RIB HAD NOT HEALED AND A PORTION OF THE RIB WAS REMOVED TO PREVENT RUBBING THAT COULD CAUSE PAIN. SCREW LOOSENING CAN BE DUE TO SEVERAL POTENTIAL CAUSES INCLUDING SURGICAL TECHNIQUE, BONE QUALITY AND DEVICE DESIGN. NO INFORMATION IS AVAILABLE ON THE DEVICE IMPLANTATION OR PATIENT BONE QUALITY SO THESE FACTORS CANNOT BE EVALUATED. IN TERMS OF DESIGN, THE ABILITY OF THE SCREWS TO LOCK TO THE PLATES AND RESIST LOOSENING WAS VERIFIED AND VALIDATED VIA DESIGN REVIEW, TOLERANCE STACK ANALYSIS, MECHANICAL TESTING AND CADAVERIC BEND TESTING. THE RESULTS CAN BE FOUND IN LEGACY REPORT/RATIONALE (B)(4) 2008 AND TOLERANCE STUDY DATED (B)(4) 2008. AS NOTED IN THE TOLERANCE STUDY, THE LOCKING SCREWS AND PLATES WERE DESIGNED PER ACCEPTED STANDARDS, (B)(4), FOR THE DIMENSION OF CONICAL LOCKING HOLES. AS NOTED IN THE LEGACY REPORT (B)(4) 2008, EVEN IN THE WORST-CASE SCENARIO OF WEAK FIXATION IN OSTEOPOROTIC RIBS, NO SCREW LOOSENING, SCREW PULL-OUT OR PLATE MIGRATION WAS DETECTED. SINCE THE DESIGN MEETS THE DESIGN CRITERIA AND THE IMPLANTATION AND PATIENT DETAILS ARE UNAVAILABLE, NO EXACT CAUSE OF SCREW LOOSENING CAN BE DETERMINED. FROM A RISK PERSPECTIVE, THE PLATE MIGRATION AND THE SCREW LOOSENING NEED TO BE CONSIDERED SEPARATELY. THE RISK OF PLATE MIGRATION IS ADDRESSED IN THE RISK ANALYSIS UNDER LINES 118 & 121. BOTH RISKS ADDRESS THE HAZARD OF PLATE MIGRATES DUE TO A CAUSE OF SCREWS LOOSEN OR PULL OUT OF BONE FOR 118 AND USER ERROR: INSUFFICIENT NUMBER OF SCREWS USED FOR 121. BASED ON THE PROVIDED INFORMATION, THE MOST LIKELY CAUSE IS SCREW LOOSENING AND WAS CONSIDERED FOR ADEQUACY. THE RISK IS ASSIGNED A SEVERITY OF HARM RATING OF 4 AND AN OCCURRENCE RATING OF 1. THE SEVERITY RATING OF 4 IS ADEQUATE SINCE IT COVERS RE-OPERATION AS OCCURRED IN THE COMPLAINT. THE OCCURRENCE RATING OF 1 IS ADEQUATE. THE RISK OF SCREW LOOSENING IS ADDRESSED IN THE RISK ANALYSIS UNDER LINES 315, 320 & 325. ALL OF THOSE RISKS ADDRESS THE HAZARD OF A SCREW LOOSENS / MIGRATES DUE TO A CAUSE OF INADEQUATE DESIGN FOR LINE 315, USER ERROR: SURGEON DOES NOT TIGHTEN SCREW UNTIL SECURE FOR LINE 320 AND POOR QUALITY BONE FOR LINE 325. BASED ON THE PROVIDED INFORMATION, NONE OF THESE CAUSES ARE DEFINITELY AT FAULT AND ALL WOULD LEAD TO THE SAME ANALYSIS SINCE THEY HAVE THE SAME HARM, HAZARD RATINGS AND OCCURRENCE RATINGS AFTER MITIGATION. THE RISKS ARE ASSIGNED A SEVERITY OF HARM RATING OF 4 AND AN OCCURRENCE RATING OF 1. THE SEVERITY RATING OF 4 IS ADEQUATE SINCE IT COVERS RE-OPERATION AS OCCURRED IN THE COMPLAINT. THE OCCURRENCE RATING OF 1 IS ADEQUATE.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    THREE SCREWS HAD COME LOOSE ON THE SAME SIDE OF THE PLATE AND AS A RESULT THAT SIDE OF THE PLATE WAS LOOSE. THE RIB HAD NOT HEALED WHEN THE IMPLANTS WERE REMOVED AND THE EXTRACTED PORTION OF THE RIB WAS REMOVED BECAUSE IT WAS RUBBING.

    Description of Event or Problem · 1

    PATIENT WAS LYING IN BED HAVING A BREATHING TREATMENT AND EXPERIENCED ABRUPT ONSET OF RIGHT INTERSCAPULAR AND RIGHT MID-THORACIC PAIN.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, A PATIENT UNDERWENT SURGERY FOR RIB PLATING. POST-OPERATIVELY, THE PATIENT PRESENTED WITH PAIN. THE SURGEON RETURNED THE PATIENT TO THE OR AND REMOVED ALL IMPLANTS AND EXTRACTED THE RIB. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201902 TI MATRIXRIB UNIVERSAL PLATE 8 HOLES HRS SYNTHES GMBH 7522111

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention