AVAflex 1031115000Recalls & reported problems
Stryker Corporation · 11 gauge 15mm AVAflex Vertebral Balloon System · Class 2
All models of AVAflex (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327374605), received between Jan 14, 2021 and Jan 11, 2024 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (6 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture6
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Foreign Body In Patient2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJan 11, 2024Fracture; Fracture
IN DECEMBER 2023, STRYKER INSTRUMENTS RECEIVED A COPY OF FDA MEDWATCH MW5148300. IT WAS REPORTED THAT DURING USE IN A KYPHOPLASTY PROCEDURE AT THE USER FACILITY, THE DEVICE FRACTURED AND A SMALL PIECE OF THE DEVICE CANNULA TIP REMAINED EMBEDDED IN THE BONE. IT WAS REPORTED THAT THE SURGEON EXTENDED AN INCISION TO EVALUATE AND ATTEMPT RETRIEVAL OF THE CANNULA TIP. THIS REPORT WILL BE FILED TO CAPTURE THE NEW INFORMATION REGARDING THE INCISION. IN 2021 STRYKER INSTRUMENTS FILED ORIGINAL MANUFACTURER REPORT (B)(4) FOR THE ORIGINALLY REPORTED MALFUNCTION.
Patient problems: Foreign Body In Patient
MAUDE report 18495350 ↗MalfunctionApr 25, 2023Fracture; Fracture
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16806631 ↗MalfunctionJan 29, 2023Fracture; Fracture
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261797 ↗MalfunctionJan 19, 2022Fracture; Fracture
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: Foreign Body In Patient
MAUDE report 13289989 ↗MalfunctionJul 21, 2021Fracture; Fracture
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12204174 ↗MalfunctionJan 14, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, WHILE THE CANNULA WAS POSITIONED IN THE PATIENT, RAPID REPOSITIONING OF THE PATIENT WAS REQUIRED TO ADDRESS AN EMERGENCY. MEDICAL PERSONNEL APPLIED SIDEWAYS FORCE WHILE REMOVING THE CANNULA AS QUICKLY AS POSSIBLE DUE TO THE EMERGENCY, BREAKING THE CANNULA. NO PATIENT HARM RESULTED FROM THE BROKEN CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11170382 ↗
Other CEMENT, BONE, VERTEBROPLASTY devices
- CONFIDENCE SPINAL CEMENT SYSTEM 283910000Medos International Sàrl · CEMENT, BONE, VERTEBROPLASTY5 deaths163 reports
- CONFIDENCE SPINAL CEMENT SYSTEM 283913000Medos International Sàrl · CEMENT, BONE, VERTEBROPLASTY8 deaths146 reports
- KYPHON® Xpede™ Bone Cement and KYPHON® Mixer Pack CX01BMedtronic Sofamor Danek, Inc. · CEMENT, BONE, VERTEBROPLASTY3 deaths67 reports
- SYNFLATE 03.804.701SSynthes GmbH · CEMENT, BONE, VERTEBROPLASTY60 reports
- KYPHON® HV-R® Bone Cement C01AMedtronic Sofamor Danek, Inc. · CEMENT, BONE, VERTEBROPLASTY57 reports
- iVAS 0705315000Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall3 reports
- Cortoss 2101-0005Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall3 reports
- iVAS 0705310000Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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