BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS TRANSLATION SCREW, UNKNOWN SIZE

    MDR report key: 9387703 · Received November 27, 2019

    Report

    Report Number
    3012447612-2019-00493
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    August 19, 2019
    Report Date
    August 14, 2020
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN B4, G4, G7, H2, H6: METHODS, RESULTS, AND CONCLUSION CODES. THE PRODUCT WAS NOT RETURNED FOR EVALUATION, HOWEVER A PHOTO WAS PROVIDED THAT SHOWS THE SCREW HAS DISASSEMBLED. THE PHOTO DOES NOT PROVIDE SUFFICIENT DETAIL TO BE ABLE TO DETERMINE ANY DAMAGE THAT MAY HAVE CONTRIBUTED TO THE DISASSEMBLY. WITHOUT PRODUCT RETURN A FULL EVALUATION CANNOT BE COMPLETED SO NO EVALUATION RESULTS ARE AVAILABLE. THE LOT NUMBER FOR THIS SPECIFIC DEVICE WAS NOT PROVIDED. THEREFORE, THE DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE PERFORMED IN THIS CASE. IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY WHERE THREE SCREWS, A PLUG, AND A TRANSVERSE CONNECTOR WERE REMOVED. A VITALITY SCREW WAS FOUND TO BE FRACTURED AND A POLARIS SCREW WAS FOUND DISASSEMBLED. THE COMPLAINT IS CONFIRMED FOR THE UNRETURNED UNKNOWN POLARIS 5.5 TRANSLATION SCREW FOR THE REPORTED FAILURE OF DISASSEMBLY. WITHOUT FURTHER INFORMATION OR PRODUCT RETURN, THE CAUSE OF THIS FAILURE AND THE REPORTED REVISION SURGERY CANNOT BE DETERMINED. AS NO MORE INFORMATION IS AVAILABLE TO EVALUATE THE REPORTED INCIDENT, THE CAUSE FOR THIS FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY WHERE THREE SCREWS, A PLUG, AND A TRANSVERSE CONNECTOR WERE REMOVED. A VITALITY SCREW WAS FOUND TO BE FRACTURED AND A POLARIS SCREW WAS FOUND DISASSEMBLED. THERE WAS NO FURTHER SURGICAL INFORMATION PROVIDED. THIS IS REPORT (B)(4) OF(B)(4).

    Additional Manufacturer Narrative · 1

    TYPE OF THE DEVICE: COMMON DEVICE NAME: POLARIS SPINAL SYSTEM OR POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM OR POLARIS SPINAL SYSTEM -TRANSLATION SCREW PMA/510(K) NUMBER: K140123 OR K123549 OR K090523. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REFERENCE REPORTS 3012447612-2019-00492 TO 3012447612-2019-00496. MW5090392

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY WHERE THREE SCREWS, A PLUG, AND A TRANSVERSE CONNECTOR WERE REMOVED. A VITALITY SCREW WAS FOUND TO BE FRACTURED AND A POLARIS SCREW WAS FOUND DISASSEMBLED. THERE WAS NO FURTHER SURGICAL INFORMATION PROVIDED. THIS IS REPORT TWO OF FIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180506 POLARIS TRANSLATION SCREW, UNKNOWN SIZE SEE H10 NKB ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R