VertaPlex HV 0406622015Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07613327170559), received between Nov 30, 2021 and Jul 22, 2026 — classified as 1 death, 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (3 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.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2026Improper or Incorrect Procedure or Method

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25907801 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PROBABLE GRADE 3 ANAPHYLACTIC SHOCK DUE TO CEMENT, SYMPTOMS INCLUDED WIDESPREAD HIVES, HYPOTENSION AND DESATURATION. MEDICAL INTERVENTION WAS REQUIRED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR MONITORING. THE PATIENT WAS DISCHARGED FROM HOSPITAL THE FOLLOWING DAY AND RETURNED HOME WITHOUT COMPLICATIONS. ON DAY 1, THE PATIENT WAS ABLE TO GET OUT OF BED. POSTURAL REHABILITATION BEGAN. THE PATIENT IS WALKING AND CAN SIT UP EASILY.

  Patient problems: Anaphylactic Shock; Hypoxia

  MAUDE report 25042563 ↗
• InjuryMar 3, 2026Migration

  NO NEW INFORMATION.

  Patient problems: Foreign Body In Patient; Hypoxia

  MAUDE report 24500679 ↗
• DeathNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SPINAL SURGICAL PROCEDURE THE CEMENT LEAKED INTO A VEIN. THE CEMENT USED WAS NOT REPORTED TO HAVE MALFUNCTIONED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A PATHOLOGIC FRACTURE AT T10 WITH CORD COMPRESSION, THE PATIENT HAD MULTIPLE METASTATIC LESIONS AT T8, T9 AND L2. IT WAS REPORTED THAT THE CEMENT PASSED THROUGH THE HEART AND WAS FLATTENED OUT ALONG THE PULMONARY ARTERY EXTENDING BOTH LEFT AND RIGHT. THE PATIENT DIED FOLLOWING THIS PROCEDURE.

  Patient problems: Embolism/Embolus

  MAUDE report 23555265 ↗
• MalfunctionOct 28, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2025 - (B)(6) 2025. THIS REPORT SUMMARIZES 1 EVENT - FOR THE FAILURE: DEVICE INGREDIENT OR REAGENT PROBLEM. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399853 ↗
• MalfunctionJul 30, 2025Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT EXPIRED CEMENT WAS USED DURING A SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665607 ↗
• MalfunctionJul 29, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: IMPROPER OR INCORRECT PROCEDURE OR METHOD. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22648117 ↗
• MalfunctionJul 14, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DUE TO THE CEMENT HARDENING, A PORTION OF THE PEAK SHEATH WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22495687 ↗
• InjuryNov 6, 2024Entrapment of Device; Entrapment of Device

  NO NEW INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 20622996 ↗
• MalfunctionOct 21, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD A DEVICE INGREDIENT OR REAGENT PROBLEM. 1 EVENT HAD PATIENT INVOLVEMENT, NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20500627 ↗
• InjuryJun 14, 2024Migration; Migration

  IT WAS REPORTED THAT DURING A KYPHOPLASTY PROCEDURE, CEMENT EXTRAVASATED INTO THE PATIENTS LUNG. IT WAS ALSO REPORTED THAT FRAGMENTS OF THE CEMENT COULD NOT BE REMOVED. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19542984 ↗
• MalfunctionNov 22, 2023Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SURGEON KNOWINGLY USED EXPIRED PRODUCT. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES 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 18192446 ↗
• MalfunctionMay 19, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE SURGEON USED EXPIRED PRODUCT. THIS REPORT IS ADDRESSING THE STERILITY RISK ASSOCIATED WITH SUCH AN EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16961399 ↗
• InjuryMay 7, 2022Improper Flow or Infusion; Thickening of Material; Improper Flow or Infusion; Thickening of Material

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE CEMENT VISCOSITY WAS TOO HIGH AND CAUSED THE DELIVERY CANNULA TO GET STUCK IN THE PATIENT. IT WAS FURTHER REPORTED THAT THE EVENT CAUSED A DELAY LEADING TO PROLONGED SURGICAL TIME AND LONGER TIME UNDER ANESTHESIA FOR THE PATIENT. IT WAS ALSO REPORTED THAT THE SURGEON PERFORMED A SPONDYLODESIS (SPINAL FUSION) TO COMPLETE THE PROCEDURE. IT WAS FURTHER REPORTED THAT A PART OF THE GUIDE SLEEVE REMAINED IN THE PATIENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 14322672 ↗
• MalfunctionApr 15, 2022Entrapment of Device; Failure to Infuse; Entrapment of Device; Failure to Infuse

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE CEMENT SET TOO QUICKLY. IT WAS ALSO REPORTED THAT THE CEMENT DELIVERY NEEDLE WAS STUCK IN THE PATIENT. IT WAS FURTHER REPORTED THAT A DECISION WAS MADE TO LEAVE THE NEEDLE IN THE PATIENT. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117525 ↗
• MalfunctionFeb 3, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE, IT WAS NOTED THAT THE SURGEON KNOWINGLY USED EXPIRED PRODUCT. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS ADDRESSING THE STERILITY RISK ASSOCIATED WITH SUCH AN EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446694 ↗
• MalfunctionNov 30, 2021Migration; Migration

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT EXTRAVASATION OF CEMENT OCCURRED. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES 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 12893752 ↗