BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM

    MDR report key: 8640083 · Received May 24, 2019

    Report

    Report Number
    8030965-2019-64507
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    April 25, 2019
    Report Date
    April 25, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    NKB
    UDI-DI
    10705034745688
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: ADDED CONCOMIATNT DEVICE. CONCOMITANT MEDICAL PRODUCTS. INITIAL REPORTER OCCUPATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: THIS MRE REVIEW IS FOR STERILIZATION PROCEDURE ONLY PART: 04.632.750S, LOT: L163031, MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 13.OCTOBER 2016, EXPIRY DATE: 01.OCTOBER 2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART WAS MANUFACTURED IN MONUMENT PART: 04.632.750, LOT: H156418, A DHR REVIEW WAS NOT PERFORMED FOR THIS PI. THIS LOT WAS MANUFACTURED BY BRANDYWINE. PLEASE REASSIGN TO THE CORRECT GROUP A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE PEDICLE SCREW MATRIX 5.5 POLYAXIAL (PART # 04.632.750S, LOT # L163031, MFG # 13-OCT-2016) WAS RECEIVED AT US CQ WITH THE SCREW HEAD DEFORMED AND MATERIAL MISSING FROM THE THREADED PORTION OF THE SCREW HEAD. THIS IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION, THUS CONFIRMING THE COMPLAINT. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS WAS NOT PERFORMED AS RELEVANT FEATURES ARE DEFORMED WITH MISSING MATERIAL. DOCUMENT/SPECIFICATION REVIEW: THE RELEVANT DRAWING(S) WAS REVIEWED; CONCLUSION: THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. CORRECTED DATA 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 · 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. 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 · 0

    CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODE: MNH, MNI, KWQ, KWP. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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) 2019, A PATIENT UNDERWENT LUMBAR SPINAL FUSION SURGERY AT L4 DUE TO LUMBAR BURST FRACTURE WITH MATRIX SPINE 5.5 SYSTEM. DURING THE SURGERY, WHEN THE SURGEON TRIED TO IMPLANT THE PEDICLE SCREW MATRIX 5.5 POLYAXIAL, THE SURGEON HAD DIFFICULTY TO HOLD THE SCREW WITH AN UNKNOWN SCREWDRIVER. THE, SURGEON THEN RECOGNIZED THAT THE SCREW HEAD SEEMED TO BE DEFORMED. THE SURGERY WAS COMPLETED BY USING AN ALTERNATIVE SCREW. AFTER THE SURGERY, THE SURGEON FOUND OUT THAT THE SCREW THREAD WAS BROKEN. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THERE WAS NO SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE AND PATIENT WAS STABLE. THIS COMPLAINT INVOLVES ONE (1) PEDICSCR MATRIX 5.5 POLYAXIAL. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434402 PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB OBERDORF SYNTHES PRODUKTIONS GMBH 04.632.750 L163031 10705034745688

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - SCREWDRIVERS