BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 3133424 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02860
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 1, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REVIEW OF THE DHR FOR LOT 6968959 SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. REVIEW OF THE DHR FOR LOT 7003294 SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. REVIEW OF THE DHR FOR LOT 7037094 (QTY 2) SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. REVIEW OF THE DHR FOR LOT 7014251 SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. LOT 6968959 WAS MANUFACTURED ON 6-20-2012. LOT 7003294 WAS MANUFACTURED ON 8-3-2012. LOT 7037094 (QTY 2) WAS MANUFACTURED ON 9-17-12. LOT 7014251 WAS MANUFACTURED ON 8-17-12. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES: MNI, MNH, KWP, KWQ. 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.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DATE DEVICE RECEIVED FOR EVALUATION. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. ADDITIONAL INFORMATION. LOT#: OBTAINED FROM DEVICES RECEIVED. ONE LOCKING CAP WAS SUBMITTED ON THE INITIAL MEDWATCH REPORT. A TOTAL OF FIVE (5) LOCKING CAPS WERE RECEIVED FOR INVESTIGATION. SYNTHES IS UNABLE TO DETERMINE WHICH LOT # POTENTIALLY CONTRIBUTED TO THE COMPLAINT EVENT; THEREFORE, ALL LOT #S ARE BEING REPORTED AS FOLLOWS: LOT # 6968959, 7003294, 7037094, 7014251, 7037094. A MANUFACTURING EVALUATION WAS CONDUCTED. VISUAL INSPECTIONS NOTED: PRODUCT A - (LOT #6968959), LOCKING CAP RECEIVED WITH ONLY SCRATCHES ON SD25 FACE. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING. PRODUCT B - (LOT #7003294), LOCKING CAP RECEIVED WITH NICKS AND SCRATCHES ON SD25 FACE AND MAJOR DIAMETER OF LOCKING SCREW AND NICKS AND SCRATCHES ON GROOVES OF THE SADDLE. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING. PRODUCT C - (LOT #7037094), LOCKING CAP RECEIVED WITH NICKS AND SCRATCHES ON SD25 FACE, ANODIZE MISSING AND NICK ON MAJOR DIAMETER OF LOCKING SCREW AND NICKS AND SCRATCHES ON GROOVES OF THE SADDLE. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING. PRODUCT D - (LOT #7037094), LOCKING CAP WAS RECEIVED WITH SCRATCHES ON SD25 FACE AND NICKS ON THE MAJOR DIAMETER. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING. PRODUCT E - (LOT #7014251), LOCKING CAP WAS RECEIVED WITH ONLY SCRATCHES ON SD25 FACE. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING. FOR ALL FIVE PRODUCTS THE RAW MATERIAL CANNOT BE MEASURED BECAUSE LACK OF SURFACE AREA, BUT RAW MATERIAL WAS VERIFIED ON DHR AS CORRECT. MEASUREMENTS THAT COULD BE TAKEN WERE FOUND TO BE WITHIN SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. INVESTIGATION IS ON-GOING. CORRECTED DATA: CORRECTED FROM PRODUCT PROBLEM TO ADVERSE EVENT. UPON FURTHER REVIEW, IT WAS DETERMINED THE DATE OF EVENT CANNOT BE DETERMINED. CORRECTION TO REPORT NUMBERS FOR THIS (B)(4). CORRECTED MANUFACTURING NAME FROM SYNTHES USA TO SYNTHES BRANDYWINE. CORRECTED FROM MALFUNCTION TO SERIOUS INJURY.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH HARDWARE ON (B)(6) 2012 FOR A LATERAL FUSION WITH POSTERIOR STABILIZATION. WHILE RECEIVING AN INJECTION ON (B)(6) 2013 THE SURGEON DETERMINED THE LOCKING CAP DISENGAGED FROM THE POLY AXIAL SCREW HEAD. DETAILS OF INJECTION ARE UNKNOWN. THERE IS NO PLANNED REVISION AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS RETURNED TO THE OPERATING ROOM (OR) ON AN UNKNOWN DATE FOR REMOVAL OF HARDWARE. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237439 TI MATRIX LOCKING CAP NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention