VertaPlex 0406622000Recalls & reported problems
Stryker Corporation · High Viscosity Radiopaque Bone Cement · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252254430), received between Aug 12, 2022 and May 15, 2025 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Migration” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Migration2
- Device Ingredient or Reagent Problem1
- Expiration Date Error1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Pain1
- Vertebral Fracture1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2025Migration; Migration
MalfunctionSep 4, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED THAT DURING A PROCEDURE, THE MONOMER AND POLYMER DID NOT MIX TO THE CORRECT CONSISTENCY, CAUSING IT TO BE TOO RUNNY FOR USE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20138223 ↗InjuryMar 4, 2024Migration; Migration
IT WAS REPORTED THAT DURING A SPINEJACK PROCEDURE AT T11, THE RADIOPAQUE MARKER FROM THE CANNULA PLUG REMAINED IN THE VERTEBRAL BODY OF THE PATIENT. THE SURGEON WAS ABLE TO POSITION THE SPINEJACKS. UPON CEMENT INJECTION FROM THE LEFT, A RAPIDLY SIGNIFICANT LEAKAGE OF CEMENT WAS OBSERVED REQUIRING IMMEDIATE SURGICAL INTERVENTION TO REMOVE THE LEAKED CEMENT. THE OPERATION LASTED AN EXTRA 2 HOURS. THE PATIENT'S CONDITION WAS CLEAR ON DISCHARGE (D+2) FOLLOWING EXTRACTION OF THE FOREIGN BODY (LEAKED CEMENT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18826039 ↗MalfunctionAug 12, 2022Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AND UPON RECEIPT, THE CEMENT PRODUCT WAS OBSERVED TO BE EXPIRED. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15218505 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.