AutoPlex, VertaPlexRecalls & reported problems across all models

We found 3 models of AutoPlex, VertaPlex by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Jan 18, 2019 and Jan 29, 2023 — classified as 2 injuries, 5 malfunctions.

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

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

AutoPlex, VertaPlex recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 9, 2017Terminated

   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 AutoPlex, VertaPlex problems

AutoPlex, VertaPlex models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AutoPlex, VertaPlex 0607687000

  MIXER, CEMENT, FOR CLINICAL USE
  1 recall4 reports
• AutoPlex, VertaPlex 0605687000

  BONE CEMENT
  2 reports
• AutoPlex, VertaPlex 0605685000

  MIXER, CEMENT, FOR CLINICAL USE
  1 report

Recent AutoPlex, VertaPlex adverse event reports

The 7 most recent reports across all models, 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 ↗
• MalfunctionOct 28, 2019Migration; Migration

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY MIGRATED FROM ITS INTENDED LOCATION. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 9245116 ↗
• MalfunctionAug 26, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE DEVICE WAS ALREADY OPENED WHEN THEY WENT TO OPEN IT UP FOR USE. THERE WAS NO PATIENT IMPACT AS THE EVENT WSA NOTICED PRIOR TO THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 8932805 ↗
• 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 ↗
• MalfunctionJan 18, 2019Migration; Migration

  IT WAS REPORTED BY THE PHYSICIAN THAT THERE WAS DISSATISFACTION WITH THE VISUALIZATION OF THE CEMENT DURING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE CEMENT LEAKED INTO THE ANTERIOR PORTION OF THE VERTEBRAL BODY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Extravasation

  MAUDE report 8261210 ↗

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