AVS TL 48370094Recalls & reported problems
Stryker Corporation · VERTEBRAL SPACER · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613153046400), received between Mar 13, 2020 and Sep 13, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Material Deformation1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2024Fracture; Fracture
IT WAS REPORTED THAT AN AVS TL PEEK SPACER FRACTURED DURING INSERTION INTRA-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20217318 ↗MalfunctionMar 13, 2020Material Deformation; Separation Problem; Material Deformation; Separation Problem
IT WAS REPORTED THAT AN AVS TL SPACER DISENGAGED INTRA-OPERATIVELY FROM THE INSERTER WHILE ATTEMPTING TO INSERT AT THE L4/5 LEVEL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A CURVED INSERTER AND A DIFFERENT CAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9829334 ↗
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- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.