Vitality® 07.02010.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00889024003170), received between Aug 27, 2019 and Oct 15, 2025 — classified as 44 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Migration” (39 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 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Migration; Migration

  IT WAS REPORTED THAT A VITAL MIS SCREW HEAD BROKE OFF DURING IMPLANT REMOVAL SURGERY. IMPLANT REMOVAL WAS PERFORMED BECAUSE THE CLOSURE TOP HAD COME OFF AND FUSION WAS COMPLETED. THERE WAS NO PATIENT HARM OR PROCEDURAL DELAY. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304351 ↗
• MalfunctionMay 27, 2025Migration; Migration

  IT WAS REPORTED THAT TWO VITAL MIS SET SCREWS MIGRATED OUT OF THEIR BONE SCREWS POST-OPERATIVELY. THIS WAS DISCOVERED VIA X-RAY DURING A FOLLOW-UP APPOINTMENT APPROXIMATELY SIX WEEKS AFTER THE INITIAL SURGERY. THE PATIENT HAS NOT BEEN SCHEDULED FOR A REVISION AND THE SURGEON WILL MONITOR THE PATIENT. THIS IS REPORT TWO OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088921 ↗
• MalfunctionMay 27, 2025Migration; Migration

  IT WAS REPORTED THAT TWO VITAL MIS SET SCREWS MIGRATED OUT OF THEIR BONE SCREWS POST-OPERATIVELY. THIS WAS DISCOVERED VIA X-RAY DURING A FOLLOW-UP APPOINTMENT APPROXIMATELY SIX WEEKS AFTER THE INITIAL SURGERY. THE PATIENT HAS NOT BEEN SCHEDULED FOR A REVISION AND THE SURGEON WILL MONITOR THE PATIENT. THIS IS REPORT ONE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088888 ↗
• InjuryMay 21, 2025Migration; Migration

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE A CLOSURE TOP THAT HAD MIGRATED OUT OF ITS MATING PEDICLE SCREW POST-OPERATIVELY. THE SURGEON DECIDED TO OBSERVE THE PATIENT FOR A FEW MONTHS BEFORE PERFORMING THE REVISION. THE ORIGINAL SCREW WAS KEPT IN PLACE AND ONLY THE CLOSURE TOP WAS EXPLANTED WITH NO PATIENT IMPACT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22063415 ↗
• MalfunctionMay 7, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT INTRA-OPERATIVELY, THE THREADS OF THREE VITALITY CLOSURE TOPS AND ONE VITAL MIS SCREW STRIPPED DURING INSERTION. A SECOND SCREW AND FOURTH PLUG WERE USED TO COMPLETE THE SURGERY, AND THERE WAS NO PATIENT IMPACT, HOWEVER THERE WAS A 20 MINUTE DELAY TO THE PROCEDURE. THIS IS REPORT THREE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978677 ↗
• MalfunctionMay 7, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT INTRA-OPERATIVELY, THE THREADS OF THREE VITALITY CLOSURE TOPS AND ONE VITAL MIS SCREW STRIPPED DURING INSERTION. A SECOND SCREW AND FOURTH PLUG WERE USED TO COMPLETE THE SURGERY, AND THERE WAS NO PATIENT IMPACT, HOWEVER THERE WAS A 20 MINUTE DELAY TO THE PROCEDURE. THIS IS REPORT TWO OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978659 ↗
• MalfunctionMay 7, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT INTRA-OPERATIVELY, THE THREADS OF THREE VITALITY CLOSURE TOPS AND ONE VITAL MIS SCREW STRIPPED DURING INSERTION. A SECOND SCREW AND FOURTH PLUG WERE USED TO COMPLETE THE SURGERY, AND THERE WAS NO PATIENT IMPACT, HOWEVER THERE WAS A 20 MINUTE DELAY TO THE PROCEDURE. THIS IS REPORT ONE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978652 ↗
• InjuryMar 18, 2025Migration; Migration

  IT WAS REPORTED THAT A WEEK POST-OPERATIVELY, A CLOSURE TOP MIGRATED OUT OF ITS MATING PEDICLE SCREW. A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE BOTH THE CLOSURE TOP AND SCREW. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634579 ↗
• MalfunctionMar 18, 2025Material Deformation; Noise, Audible; Material Deformation; Noise, Audible

  IT WAS REPORTED THAT INTRA-OPERATIVELY, A CLOSURE TOP CROSS-THREADED AND MADE A STRANGE NOISE, SO THE SURGEON REMOVED AND REPLACED IT WITH ANOTHER CLOSURE TOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634227 ↗
• InjuryMar 12, 2025Migration; Migration

  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 FOUR OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21588280 ↗
• InjuryMar 12, 2025Migration; Migration

  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 TWO OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21588278 ↗
• InjuryMar 12, 2025Migration; Migration

  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 SEVEN OF NINE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587714 ↗
• InjuryMar 12, 2025Migration; Migration

  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 FIVE OF NINE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587694 ↗
• InjuryMar 12, 2025Migration; Migration

  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 THREE OF NINE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587679 ↗
• InjuryMar 12, 2025Migration; Migration

  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 ONE OF NINE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587635 ↗
• InjuryMar 12, 2025Migration; Migration

  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 THREE OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586641 ↗
• InjuryMar 12, 2025Migration; Migration

  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 ONE OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586608 ↗
• MalfunctionFeb 26, 2025Migration; Migration

  IT WAS REPORTED THAT A SPINAL FUSION PATIENT WAS FOUND TO HAVE TWO CLOSURE TOPS AT L3 AND L5 THAT MIGRATED OUT OF THEIR MATING PEDICLE SCREWS. THIS WAS DISCOVERED VIA X-RAY DURING A FOLLOW-UP APPOINTMENT APPROXIMATELY THREE WEEKS POST-OPERATIVELY. THE PATIENT IS ASYMPTOMATIC AND IS CONSULTING WITH THEIR SURGEON TO DETERMINE IF A REVISION IS NECESSARY. THIS IS REPORT ONE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472947 ↗
• MalfunctionFeb 26, 2025Migration; Migration

  IT WAS REPORTED THAT A SPINAL FUSION PATIENT WAS FOUND TO HAVE TWO CLOSURE TOPS AT L3 AND L5 THAT MIGRATED OUT OF THEIR MATING PEDICLE SCREWS. THIS WAS DISCOVERED VIA X-RAY DURING A FOLLOW-UP APPOINTMENT APPROXIMATELY THREE WEEKS POST-OPERATIVELY. THE PATIENT IS ASYMPTOMATIC AND IS CONSULTING WITH THEIR SURGEON TO DETERMINE IF A REVISION IS NECESSARY.THIS IS REPORT TWO OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472946 ↗
• InjuryFeb 26, 2025Migration; Migration

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO CORRECT A MIGRATED CLOSURE TOP AT LEFT L4, SUBSIDENCE OF THE TLIF CAGE (COMPETITIVE), AND A LOOSENING OF A PEDICLE SCREW AT L5. THE PATIENT REPORTED PAIN ON THE LEFT SIDE. EVERY SCREW IN THE CONSTRUCT WAS REMOVED AND REPLACED WITH LARGER DIAMETER SCREWS; ADDITIONALLY, THE CONSTRUCT WAS EXTENDED TO S1. THIS IS REPORT TWO OF THREE FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 21470770 ↗
• MalfunctionFeb 18, 2025Migration; Migration

  IT WAS REPORTED THAT A CLOSURE TOP MIGRATED OUT OF AN ILIAC SCREW POST-OPERATIVELY PER X-RAY. CURRENTLY, PLANS FOR A REVISION SURGERY ARE UNKNOWN. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21406165 ↗
• InjuryJan 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS TWO CLOSURE TOPS THAT MIGRATED OUT OF THEIR MATING SCREWS POST-OPERATIVELY. DURING THE REVISION, AN ADDITIONAL FIVE CLOSURE TOPS WERE FOUND TO BE LOOSE IN THE CONSTRUCT. ALL SEVEN CLOSURE TOPS AND SCREWS WERE REMOVED AND REPLACED DURING THE REVISION. THIS IS REPORT SEVEN OF FOURTEEN FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21061788 ↗
• InjuryJan 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS TWO CLOSURE TOPS THAT MIGRATED OUT OF THEIR MATING SCREWS POST-OPERATIVELY. DURING THE REVISION, AN ADDITIONAL FIVE CLOSURE TOPS WERE FOUND TO BE LOOSE IN THE CONSTRUCT. ALL SEVEN CLOSURE TOPS AND SCREWS WERE REMOVED AND REPLACED DURING THE REVISION. THIS IS REPORT SIX OF FOURTEEN FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21061774 ↗
• InjuryJan 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS TWO CLOSURE TOPS THAT MIGRATED OUT OF THEIR MATING SCREWS POST-OPERATIVELY. DURING THE REVISION, AN ADDITIONAL FIVE CLOSURE TOPS WERE FOUND TO BE LOOSE IN THE CONSTRUCT. ALL SEVEN CLOSURE TOPS AND SCREWS WERE REMOVED AND REPLACED DURING THE REVISION. THIS IS REPORT FIVE OF FOURTEEN FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21061747 ↗
• InjuryJan 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS TWO CLOSURE TOPS THAT MIGRATED OUT OF THEIR MATING SCREWS POST-OPERATIVELY. DURING THE REVISION, AN ADDITIONAL FIVE CLOSURE TOPS WERE FOUND TO BE LOOSE IN THE CONSTRUCT. ALL SEVEN CLOSURE TOPS AND SCREWS WERE REMOVED AND REPLACED DURING THE REVISION. THIS IS REPORT FOUR OF FOURTEEN FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21061731 ↗