BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRUT, SMALL, 08MM

    MDR report key: 11619193 · Received April 6, 2021

    Report

    Report Number
    3012447612-2021-00116
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    March 12, 2021
    Report Date
    July 22, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    MQP
    PMA / PMN Number
    K031672
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE ITEM WAS RETURNED DISASSEMBLED. THERE IS NO VISUAL DEFORMITY ON THE ITEMS OTHER THAN DISASSEMBLY. PROVIDED X-RAYS SHOW THE POST-OPERATIVE DISASSEMBLY WITHIN THE PATIENT. POTENTIAL CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO ADVERSE POST-OPERATIVE EVENTS, PATIENT FACTORS OR OTHER UNKNOWN OPERATIONAL FACTORS. DHR REVIEW PER DHR REVIEW, THE PARTS WERE LIKELY CONFORMING WHEN THEY LEFT ZIMMER BIOMET CONTROL. DEVICE USE THIS DEVICE IS USED FOR TREATMENT. 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.

    Additional Manufacturer Narrative · 0

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND INITIALLY CORRECTED INFORMATION. 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 DURING A 6 WEEK FOLLOW UP VISIT, X-RAYS SHOWED THAT THE CONSTRUCT LOCATED AT L5/S1 WAS COMPLETELY DISASSEMBLED. THE STRUTS WERE NO LONGER ATTACHED INSIDE THE ENDPLATES AND WERE FLOATING INTERNALLY. A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE CONSTRUCT. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A 6 WEEK FOLLOW UP VISIT, X-RAYS SHOWED THAT THE CONSTRUCT LOCATED AT L5/S1 WAS COMPLETELY DISASSEMBLED. THE STRUTS WERE NO LONGER ATTACHED INSIDE THE ENDPLATES AND WERE FLOATING INTERNALLY. A REVISION SURGERY WAS PERFORMED WHERE THE ORIGINAL HARDWARE WAS REMOVED AND REPLACED. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A 6 WEEK FOLLOW UP VISIT, X-RAYS SHOWED THAT THE CONSTRUCT LOCATED AT L5/S1 WAS COMPLETELY DISASSEMBLED. THE STRUTS WERE NO LONGER ATTACHED INSIDE THE ENDPLATES AND WERE FLOATING INTERNALLY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. THE SURGEON REMOVED ORIGINAL HARDWARE AND REPLACED IT. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.

    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. REFERENCE REPORTS 3012447612-2021-00113.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A 6 WEEK FOLLOW UP VISIT, X-RAYS SHOWED THAT THE CONSTRUCT LOCATED AT L5/S1 WAS COMPLETELY DISASSEMBLED. THE STRUTS WERE NO LONGER ATTACHED INSIDE THE ENDPLATES AND WERE FLOATING INTERNALLY. A DECISION ON FURTHER PATIENT CARE HAS NOT YET BEEN MADE. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521321 STRUT, SMALL, 08MM INFIX SYSTEM MQP ZIMMER BIOMET SPINE INC. N/A AA46

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R