AutoPlex, VertaPlex 0607687000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252039259), received between May 3, 2019 and Jan 29, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 reports).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 9, 2017Class IITerminated

   Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

   Z-1250-2018 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. -1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261893 ↗
• MalfunctionJul 26, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15107792 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PHYSICIAN TO THE SALES REP THAT A FEW DAYS AFTER A KYPHOPLASTY PROCEDURE WAS SUCCESSFULLY COMPLETED THAT THE PATIENT RETURNED COMPLAINING OF SHORTNESS OF BREATH. UPON IMAGING IT WAS OBSERVED THAT CEMENT HAD EXTRAVASATED TO THE HEART. OPEN HEART SURGERY WAS PERFORMED TO REMOVE THE CEMENT. A MAJORITY OF THE CEMENT WAS SUCCESSFULLY REMOVED EXCEPT FOR ONE PIECE THAT WAS LEFT BEHIND. AFTER FURTHER FOLLOW UP, IT WAS REPORTED THAT THE PATIENT REQUESTED A SECOND SURGERY TO REMOVE THE PIECE OF CEMENT THAT WAS LEFT BEHIND AND THAT DURING THAT SECOND SURGERY, THE PIECE OF CEMENT MIGRATED TO THE LUNGS AND WAS NOT REMOVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AT THAT TIME. IT WAS FURTHER REPORTED THAT THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF SHORTNESS OF BREATH. AT THE TIME OF THIS REPORT, THE PATIENT WAS REPORTED TO BE ADMITTED AT THE HOSPITAL. UPON ADDITIONAL FOLLOW UP WITH THE REP, THE REP WAS INFORMED THAT THE PATIENT HAS A HISTORY OF BREAST CANCER.

  Patient problems: Foreign Body In Patient

  MAUDE report 8619594 ↗
• InjuryMay 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WHO HAD RECEIVED A VERTEBRALPLASTY PROCEDURE HAD RETURNED TO THE HOSPITAL COMPLAINING OF SHORTNESS OF BREATH. AFTER A CT SCAN WAS PERFORMED, CEMENT WAS LOCATED IN THE PATIENT'S LUNGS AND HEART. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY.

  Patient problems: Extravasation

  MAUDE report 8578444 ↗