BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULATED TRANSLATION SCREW, UNKNOWN SIZE

    MDR report key: 10938222 · Received December 3, 2020

    Report

    Report Number
    3012447612-2020-00677
    Event Type
    Injury
    Date Received
    December 3, 2020
    Date of Event
    October 29, 2020
    Report Date
    March 10, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. SUMMARY: THE COMPLAINT IS CONFIRMED FOR ONE (1) OF ONE (1) UNRETURNED CYPHER MIS 5.5 TI 5.0X145MM (PN: 14-571XXX) FOR THE FAILURE OF PATIENT HARM. THE PRODUCT WAS NOT RETURNED FOR EVALUATION, HOWEVER, X-RAYS WERE PROVIDED. THE PROVIDED X-RAYS DO NOT REVEAL ANY ISSUES WITH THE IMPLANTS. HOWEVER, IT CAN BE OBSERVED THAT A PORTION OF THE SACRUM BONE IS FRACTURED. POTENTIAL CAUSE EVEN THOUGH THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, THE PROVIDED DATA IN THE COMPLAINT DESCRIPTION SUGGESTS THAT THE CAUSE IS LIKELY NOT TRACED TO THE DEVICE. PER THE COMPLAINT DESCRIPTION, THE PATIENT HAS GONE THROUGH MULTIPLE PROCEDURES WHICH COULD HAVE WEAKEN THE PATIENT BONE, LEADING TO THIS EVENT. ADDITIONALLY, IT SHOULD BE NOTED THAT THE PATIENT IS SHORT AND OVERWEIGHT WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. DHR REVIEW AND RELATED ACTIONS LOT NUMBER WAS NOT PROVIDED, THEREFORE, DHR REVIEW CAN'T BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED THAT CHANGES THE INFORMATION PROVIDED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION IN H10: D2 COMMON DEVICE NAME: POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW. PLACEMENT SYSTEM OR POLARIS SPINAL SYSTEM -TRANSLATION SCREW. G5 510K NUMBER: K123549 OR K140123. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BLADE MAY HAVE BROKEN OFF A PORTION OF THE SACRUM POST-OPERATIVELY. NO INFORMATION REGARDING TREATMENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BLADE MAY HAVE BROKEN OFF A PORTION OF THE SACRUM POST-OPERATIVELY. NO INFORMATION REGARDING TREATMENT HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADE MAY HAVE BROKEN OFF A PORTION OF THE SACRUM POST-OPERATIVELY. NO INFORMATION REGARDING TREATMENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402446 CANNULATED TRANSLATION SCREW, UNKNOWN SIZE SEE H10 NKB ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other