BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 10578103 · Received September 23, 2020

    Report

    Report Number
    3012447612-2020-00533
    Event Type
    Injury
    Date Received
    September 23, 2020
    Date of Event
    September 1, 2020
    Report Date
    January 5, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    K150896
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D1: TOP LOADING POLY SCREW ASSEMBLIES 7.5X45MM; TOP LOADING POLY REDUCTION SCREW ASSEMBLIES 7.5X45MM; OR TOP LOADING POLY REDUCTION SCREW ASSEMBLIES 6.5X45MM. D4 CATALOG NUMBER: 07.02000.117, 07.02001.117, OR 07.02001.075. D4 LOT NUMBER: P140872, P140893, P140949, OR T09967. D4 UDI NUMBER: (B)(4). H4: NOV 24, 2015, JAN 7, 2016, NOV 10, 2015, OR SEP 7, 2018. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS UNREFUTED FOR THREE (3) OF SIX (6) RETURNED VITALITY SCREWS FOR THE FAILURE OF UNABLE TO ADEQUATELY LOCK AND RETAIN THE CLOSURE TOPS. SPECIFICALLY WHICH SCREW IS ASSOCIATED WITH THE CLOSURE TOPS WAS UNABLE TO BE DETERMINED. POTENTIAL CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO TLD OUTPUTTING TORQUE BELOW SPECIFICATION, SCREW TULIP HEAD TABS SPLAYING UPON TAB REMOVAL OR INSERTION OF THE CLOSURE TOPS, IMPROPER TIGHTENING OF THE CLOSURE TOPS, TRAUMA OR INADEQUATE ROD REDUCTION. COMPLAINT HISTORY: A REVIEW OF PRIOR COMPLAINT HISTORY WAS CONDUCTED. DHR REVIEW AND RELATED ACTIONS PER THE DHR REVIEW, THE SCREWS WERE LIKELY CONFORMING WHEN THEY LEFT ZIMMER BIOMET CONTROL. NO ACTIONS ARE REQUIRED. THIS EVENT IS NOT RELATED TO ANY CURRENT ACTIONS OR RECALLS OR PRODUCT HOLDS. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED THAT CHANGES THE INFORMATION PROVIDED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY AFTER 3 SET SCREWS MIGRATED OUT OF THEIR MATING SCREWS AND TWO CAGES MIGRATED WITHIN THE DISC SPACE POSTOPERATIVELY. THE SCREW CONSTRUCT WAS REMOVED, THE CAGES WERE REPOSITIONED, AND A NEW SCREW CONSTRUCT WAS IMPLANTED TO COMPLETE THE CASE. THERE WERE NO ADDITIONAL PATIENT IMPACTS REPORTED. THIS IS REPORT 2 OF 8 FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    BRAND NAME: TOP LOADING POLY REDUCTION SCREW ASSEMBLIES 7.5X45MM OR TOP LOADING POLY SCREW ASSEMBLIES 6.5X45MM. CATALOG NUMBER: 07.02000.075 OR 07.02001.117. 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 3012447612-2020-00532 TO 3012447612-2020-00538 AND 3012447612-2020-00540.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY AFTER 3 SET SCREWS MIGRATED OUT OF THEIR MATING SCREWS AND TWO CAGES MIGRATED WITHIN THE DISC SPACE POSTOPERATIVELY. THE SCREW CONSTRUCT WAS REMOVED, THE CAGES WERE REPOSITIONED, AND A NEW SCREW CONSTRUCT WAS IMPLANTED TO COMPLETE THE CASE. THERE WERE NO ADDITIONAL PATIENT IMPACTS REPORTED. THIS IS REPORT 2 OF 8 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042597 SEE H10 VITALITY SPINAL FIXATION SYSTEM NKB ZIMMER BIOMET SPINE INC. NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R