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iVAS 0705310000Recalls & reported problems

Stryker Corporation · Inflatable Vertebral Augmentation System · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252505983), received between Oct 28, 2019 and Oct 28, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Nov 9, 2017Terminated

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

    Z-1254-2018 · Root cause: Environmental control · FDA record ↗

Most reported problems

Device problems

  • Break1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 28, 2019Break; Break

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD A BROKEN CUTTING ACCESSORY STILL ATTACHED. 1 EVENT HAD A FRAGMENT OF THE DEVICE BREAK OFF AND REMAIN IN THE PATIENT. THERE WAS PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 9245117 ↗

Other CEMENT, BONE, VERTEBROPLASTY devices

All CEMENT, BONE, VERTEBROPLASTY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.