Vital™ MIS Spinal Fixation System 824M6545Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00887868513831), received between Feb 13, 2023 and Mar 12, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  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 21588344 ↗
• InjuryMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  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 21588213 ↗
• InjuryMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  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 EIGHT OF NINE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587806 ↗
• InjuryMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  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 SIX OF NINE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587697 ↗
• InjuryMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  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 FOUR OF NINE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587685 ↗
• InjuryMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  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 TWO OF NINE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587665 ↗
• InjuryMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  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 21586651 ↗
• InjuryMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  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 21586629 ↗
• InjuryJun 15, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT 12 DAYS AFTER SURGERY, THE PATIENT HEARD A NOISE FROM THE IMPLANTS AND AN X-RAY FOUND THAT THE CLOSURE TOP AND ROD HAD MIGRATED OUT OF THE PEDICLE SCREW ON THE LEFT SIDE OF L5. A REVISION SURGERY WAS PERFORMED TO REMOVE THE PEDICLE SCREW, ROD, AND CLOSURE TOP AND REPLACE THEM WITH ANOTHER PEDICLE SCREW, ROD, AND CLOSURE TOP. THERE WERE NO INJURIES THAT OCCURRED DURING THE REVISION SURGERY. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 17133823 ↗
• InjuryApr 14, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A CLOSURE TOP WAS FOUND TO HAVE MIGRATED OUT OF THE MATING VITAL MIS SCREW VIA X-RAY TAKEN AT THE PATIENT'S ONE MONTH POSTOPERATIVE APPOINTMENT. A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE SCREW AND CLOSURE TOP. THE REVISION SURGERY WAS A SUCCESS WITHOUT ANY ISSUES. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16746929 ↗
• InjuryFeb 13, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A CLOSURE TOP WAS FOUND TO HAVE BACKED OUT OF ITS MATING PEDICLE SCREW ON X-RAYS TAKEN DURING A POST-OP FOLLOW-UP VISIT. A SMALL OF AMOUNT OF KYPHOSIS DEVELOPED AROUND THE SCREW BUT DID NOT CAUSE ANY PAIN FOR THE PATIENT. A REVISION SURGERY WAS SUBSEQUENTLY PERFORMED TO REMOVE THE CONSTRUCT BECAUSE IT WAS NO LONGER NEEDED. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 16362257 ↗