Vertecem II Cement Kit 08.702.017SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04260056880759), received between Oct 25, 2018 and Jul 20, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2023Unsealed Device Packaging; Device Damaged Prior to Use; Unsealed Device Packaging; Device Damaged Prior to Use

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A VERTECEM II MIXING KIT AND VERTECEM V+ SYRINGE KIT FOR A KYPHOPLSTY CASE DID NOT HAVE INTACT STERILE SEALS SO THE PHYSICIAN DID NOT WANT TO USE THEM AND WOULD LIKE REPLACEMENTS. BACK UP STOCK WAS AVAILABLE AND HE USED THOSE. NO EFFECT ON PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17360025 ↗
• MalfunctionAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A KYPHOPLASTY CASE, THE SURGEON REPORTED THAT THE VERTECEM II MIXING KIT SOLIDIFIED IN 5 MINUTES. THE STAFF REPORTED THAT THEY TRIED A SECOND KIT WHICH ALSO SOLIDIFIED IN AN UNUSUALLY QUICK TIME PERIOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED. NO MORE INFORMATION HAS BEEN PROVIDED BY THE USER FACILITY. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12352647 ↗
• InjuryAug 17, 2020Use of Incorrect Control/Treatment Settings; Patient Device Interaction Problem; Use of Incorrect Control/Treatment Settings; Patient Device Interaction Problem

  IT WAS REPORTED THAT, THE VERTECEM II CEMENT WAS NOTICED TO HAVE EXTRUDED INTO THE PATIENT'S VENA CAVA. INITIALLY, THE PATIENT UNDERWENT AN L4 CORPECTOMY WITH SCREWS AND VERTECEM CEMENT AT L3-5 ON (B)(6) 2020. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS A PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (LOT # UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Failure of Implant; No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 10412947 ↗
• MalfunctionApr 24, 2019Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT UNKNOWN PROCEDURE AT LEVEL T8 ON (B)(6) 2019 DUE TO VERTEBRAL COMPRESSION FRACTURES. DURING THE PROCEDURE THE SURGICAL TECH WAS TRYING TO MIX THE VERTECEM II MIX KIT. THE T-HANDLE WAS STUCK AND NEVER ALLOWED HER TO MIX. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) VERTECEM II MIXING KIT-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546245 ↗
• MalfunctionOct 25, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, UPON MIXING AND OPENING THE MIXER TO DISPENSE, VERTECEM CEMENT SPILLED OUT OF THE MIXER AS IF UNDER PRESSURE. THIS HAPPENED TO TWO (2) MIXERS AND SEEMED TO HAVE PRESSURE IN MIXING VALVE. CEMENT CAME OUT BEFORE STOP COCK COULD BE APPLIED BUT ONCE STOP COCK WAS ATTACHED EVERYTHING WAS FINE. THIS MIGHT BE DUE TO A TECHNICAL ERROR IN MIXING AGGRESSIVELY ON THE BACK TABLE. SUFFICIENT CEMENT REMAINED AND WAS OF NORMAL VISCOSITY, SO THERE WAS NO IMPACT ON THE PATIENT AND NO DELAY ON THE LENGTH OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT AND THE PATIENT OUTCOME WAS GOOD. THIS REPORT IS FOR ONE (1) VERTECEM II MIXING KIT-STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8006473 ↗
• MalfunctionOct 25, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, UPON MIXING AND OPENING THE MIXER TO DISPENSE, VERTECEM CEMENT SPILLED OUT OF THE MIXER AS IF UNDER PRESSURE. THIS HAPPENED TO TWO (2) MIXERS AND SEEMED TO HAVE PRESSURE IN MIXING VALVE. CEMENT CAME OUT BEFORE STOP COCK COULD BE APPLIED BUT ONCE STOP COCK WAS ATTACHED EVERYTHING WAS FINE. THIS MIGHT BE DUE TO A TECHNICAL ERROR IN MIXING AGGRESSIVELY ON THE BACK TABLE. SUFFICIENT CEMENT REMAINED AND WAS OF NORMAL VISCOSITY, SO THERE WAS NO IMPACT ON THE PATIENT AND NO DELAY ON THE LENGTH OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT AND THE PATIENT OUTCOME WAS GOOD. THIS REPORT IS FOR ONE (1) VERTECEM II MIXING KIT-STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8006460 ↗