Vitality® 07.02053.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00889024009790), received between Mar 13, 2020 and May 21, 2025 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT INTRA-OPERATIVELY, TWO TORQUE LIMITING HANDLES DID NOT PROVIDE ADEQUATE TORQUE, ALLOWING FOR ROD MOVEMENT DURING COMPRESSION. ANOTHER TORQUE HANDLE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT IMPACT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060405 ↗
• MalfunctionMay 21, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT INTRA-OPERATIVELY, TWO TORQUE LIMITING HANDLES DID NOT PROVIDE ADEQUATE TORQUE, ALLOWING FOR ROD MOVEMENT DURING COMPRESSION. ANOTHER TORQUE HANDLE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT IMPACT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060398 ↗
• InjuryMar 12, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT TWO VITAL MIS SET SCREWS MIGRATED FROM THEIR MATING POLYAXIAL PEDICLE SCREWS POST-OPERATIVELY. THIS WAS DISCOVERED APPROXIMATELY TWO WEEKS POST-OP VIA X-RAY. THE PATIENT IS CURRENTLY ASYMPTOMATIC BUT THE SURGEON IS PLANNING TO REVISE THE CONSTRUCT. THE SURGEON BELIEVES THAT THE TORQUE HANDLE USED DID NOT PROVIDE ADEQUATE TORQUE. THIS IS REPORT FIVE OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21588305 ↗
• InjuryMar 12, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT FOUR VITAL MIS SET SCREWS MIGRATED FROM THEIR MATING POLYAXIAL PEDICLE SCREWS POST-OPERATIVELY. THIS WAS DISCOVERED APPROXIMATELY TWO WEEKS POST-OP VIA X-RAY. THE PATIENT IS CURRENTLY ASYMPTOMATIC BUT THE SURGEON IS PLANNING TO REVISE THE CONSTRUCT. THE SURGEON BELIEVES THAT THE TORQUE HANDLE USED DID NOT PROVIDE ADEQUATE TORQUE. THIS IS REPORT NINE OF NINE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587789 ↗
• InjuryMar 12, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT TWO VITAL MIS SET SCREWS MIGRATED FROM THEIR MATING POLYAXIAL PEDICLE SCREWS POST-OPERATIVELY. THIS WAS DISCOVERED APPROXIMATELY TWO WEEKS POST-OP VIA X-RAY. THE PATIENT IS CURRENTLY ASYMPTOMATIC BUT THE SURGEON IS PLANNING TO REVISE THE CONSTRUCT. THE SURGEON BELIEVES THAT THE TORQUE HANDLE USED DID NOT PROVIDE ADEQUATE TORQUE. THIS IS REPORT FIVE OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586661 ↗
• MalfunctionMar 7, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING A SINGLE LEVEL TLIF CASE, AFTER FINAL TIGHTENING OF A CLOSURE TOP, THE CLOSURE TOP AND PEDICLE SCREW LOST COMPRESSION. THIS WAS DUE TO THE TORQUE HANDLE PROVIDING INADEQUATE TORQUE. THE SURGERY WAS COMPLETED USING A DISPOSABLE TORQUE HANDLE TO SUCCESSFULLY PERFORM THE FINAL LOCKING AGAIN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21548723 ↗
• MalfunctionSep 5, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE TIPS OF TWO VITAL T27 FINAL DRIVERS FRACTURED DURING SURGERY AND A TORQUE LIMITING HANDLE TOOK MORE FORCE THAN USUAL TO TORQUE. THE FIRST BROKEN TIP OF THE SET SCREWDRIVER WAS RETRIEVED, BUT THE SECOND TIP REMAINED IN THE SET SCREW IN THE PATIENT BODY. A 30 MINUTE DELAY TO THE SURGERY WAS ALSO REPORTED. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20148498 ↗
• MalfunctionOct 14, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT A SURGEON FEELS THE VITALITY DRIVER WAS NOT CALIBRATED CORRECTLY, AND DID NOT OUTPUT ENOUGH TORQUE ON THE CLOSURE TOPS DURING SURGERY. THERE HAVE BEEN NO REPORTED PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606927 ↗
• MalfunctionOct 14, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE SURGEON FEELS THE TORQUE LIMITING HANDLE WAS NOT CALIBRATED CORRECTLY, AND DID NOT OUTPUT ENOUGH TORQUE ON THE CLOSURE TOPS DURING SURGERY. THERE HAVE BEEN NO PATIENT IMPACTS REPORTED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606833 ↗
• MalfunctionFeb 25, 2022Calibration Problem; Calibration Problem

  THREE TORQUE LIMITING HANDLES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION AS PART OF A CONCERN WITH MALFUNCTIONING DRIVERS. THE TORQUE HANDLES WERE SUBSEQUENTLY TESTED AND FOUND TO OUTPUT TORQUE ABOVE THE REQUIRED LIMIT. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 13606848 ↗
• MalfunctionFeb 25, 2022Calibration Problem; Calibration Problem

  THREE TORQUE LIMITING HANDLES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION AS PART OF A CONCERN WITH MALFUNCTIONING DRIVERS. THE TORQUE HANDLES WERE SUBSEQUENTLY TESTED AND FOUND TO OUTPUT TORQUE ABOVE THE REQUIRED LIMIT. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 13606843 ↗
• MalfunctionFeb 25, 2022Calibration Problem; Calibration Problem

  THREE TORQUE LIMITING HANDLES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION AS PART OF A CONCERN WITH MALFUNCTIONING DRIVERS. THE TORQUE HANDLES WERE SUBSEQUENTLY TESTED AND FOUND TO OUTPUT TORQUE ABOVE THE REQUIRED LIMIT. THIS IS REPORT TWO OF THREE FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 13606837 ↗
• MalfunctionMar 13, 2020Calibration Problem; Calibration Problem

  T WAS REPORTED THAT DURING THE PROCEDURE TWO TORQUE HANDLES WERE PROVIDING INCONSISTENT TORQUE. THERE WAS NO FURTHER SURGICAL INFORMATION PROVIDED HOWEVER, IT WAS REPORTED THAT A CLOSURE TOP, TIGHTENED BY ONE OF THE TORQUE HANDLES, WAS FOUND TO HAVE BACKED OUT 3 MONTHS POSTOPERATIVELY. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9830678 ↗