BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIS TI CFX FEN POLY 6X45

    MDR report key: 9530303 · Received December 30, 2019

    Report

    Report Number
    1526439-2019-52811
    Event Type
    Injury
    Date Received
    December 30, 2019
    Report Date
    December 3, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    PML
    UDI-DI
    10705034072531
    PMA / PMN Number
    K160879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. H10 ADDITIONAL NARRATIVE: B5: UPDATED CONCOMITANT PRODUCT. B6: UPDATED TESTS/LAB DATA. D2: ADDITIONAL CODE MNI. H3, H6: INVESTIGATION SUMMARY, INVESTIGATION FLOW: DAMAGE , VISUAL INSPECTION: THE MIS TI CFX FEN POLY 6X45 (P/N: (B)(4), LOT NUMBER: 168857) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THAT THE TULIP HEAD OF THE SCREW AND PART OF THE BALL HEAD HAVE BROKEN OFF FROM THE REMAINDER OF THE BALL HEAD AND THE SCREW SHANK. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE TULIP HEAD OF THE SCREW AND PART OF THE BALL HEAD HAVE BROKEN OFF FROM THE REMAINDER OF THE BALL HEAD AND THE SCREW SHANK. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT. THE DHR OF PRODUCT CODE 186727645, LOT 168857, WAS REVIEWED AND NO NON-CONFORMANCES WERE OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON (B)(6) 2017. THE DHR WAS ELECTRONICALLY REVIEWED. 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

    SURGICAL REMOVAL OF THE SYSTEM DUE TO A SUSPECTED RUPTURE OF SCREW/S AND ROD/S. EXPLANTATION DATE: (B)(6) 2019. CONCOMITANT DEVICE REPORTED: ROD (PART# 1867-89-120, LOT# TBFAP, QUANTITY 2), POLYAXIAL SCREW 6X30 (PART# 1867-27-630, LOT# 184676, QUANTITY 3), POLYAXIAL SCREW 6X45 (PART# 1867-27-645, LOT# 168857, QUANTITY 3), SINGLE- INNER SET SCREW (PART# 1867-15-000, LOT# 194154, QUANTITY 2), SINGLE-INNER SET SCREW (PART# 1867-15-000, LOT# 182988, QUANTITY 4), SINGLE-INNER SET SCREW (PART# 1867-15-000, LOT# 181885, QUANTITY 1), SINGLE-INNER SET SCREW (PART# 1867-15-000, LOT# UNKNOWN, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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. (B)(4). 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

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE VIPER E CORTICAL FIX SYSTEM WAS REMOVED DUE TO LOW BACK PAIN FOLLOWING PHYSICAL ACTIVITY. IT WAS DETERMINED THAT THE PEDICLE SCREW WAS BROKEN IN L5, THEREFORE THE IMPLANT WAS REMOVED AFTER HEALING OF THE L2 L3 L4 FRACTURES. THE SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2018 DUE TO A FRACTURE OF THE L2/L3/L4. CONCOMITANT MEDICAL DEVICES: LORDOTIC ROD (PART#186788120, LOT# UNKNOWN, QUANTITY 1). UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE EXP 5.5 TI IDE FEN 6X45MM. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324239 MIS TI CFX FEN POLY 6X45 BONE CEMENT, POSTERIOR SCREW AUGMENTATION PML MEDOS INTERNATIONAL SàRL CH 168857 10705034072531

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MIS SINGLE INNER SETSCW| MIS TI CFX FEN POLY 6X30| MIS TI CFX FEN POLY 6X45| UNKNOWN PLATES| VIPER2 LORDOTIC ROD-120MM| VIPER2 LORDOTIC ROD-120MM