VITALITY® 701M6540Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304867505), received between Oct 21, 2020 and Nov 22, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Biocompatibility” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A VITALITY CLOSURE TOP MIGRATED OUT OF IT'S MATING POLYAXIAL SCREW POST-OPERATIVELY. THE ORIGINAL CONSTRUCT WAS AN L3/4 PLIF USING A COMPETITIVE CAGE. ONE MONTH POSTOPERATIVELY, IT WAS CONFIRMED THAT THE L3 LEFT SET SCREW WAS LOOSENING, AND THREE MONTHS AFTER THE SURGERY, IT WAS CONFIRMED THAT THE SET SCREW WAS COMPLETELY POPPED OFF. A REVISION SURGERY WAS PERFORMED. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20765982 ↗
• InjuryJul 11, 2022Loosening 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 A CLOSURE TOP THAT MIGRATED OUT OF THE SCREW AT S1. AT THE PATIENT'S POST-OPERATIVE FOLLOW-UP APPOINTMENT, THE X-RAY REVEALED THE CLOSURE TOP WAS BACKING OUT OF THE SCREW. THE CONSTRUCT WAS FROM L2-S1. PATIENT WAS REVISED WITH A NEW SCREW AT THE S1 LEVEL WITH ALL NEW CLOSURE TOPS ON THAT SIDE OF THE CONSTRUCT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14983058 ↗
• InjuryJul 11, 2022Loosening 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 A CLOSURE TOP THAT MIGRATED OUT OF THE SCREW AT S1. AT THE PATIENT'S POST-OPERATIVE FOLLOW-UP APPOINTMENT, THE X-RAY REVEALED THE CLOSURE TOP WAS BACKING OUT OF THE SCREW. THE CONSTRUCT WAS FROM L2-S1. PATIENT WAS REVISED WITH A NEW SCREW AT THE S1 LEVEL WITH ALL NEW CLOSURE TOPS ON THAT SIDE OF THE CONSTRUCT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982971 ↗
• InjuryOct 21, 2020Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT IS HAVING A POSSIBLE ALLERGIC REACTION TO SOME SPINAL IMPLANTS. THE INSTALLED IMPLANTS INCLUDE AN EPIC CONSTRUCT AND A BRECKENRIDGE CAGE. THE PATIENT IS ALLERGIC TO NICKEL AND MAY BE SENSITIVE TO COBALT CHROME. ALLERGY TESTS ARE ON-GOING AND A PLAN FOR CARE HAS NOT YET BEEN MADE. THIS IS REPORT EIGHT OF 14 FOR THIS EVENT.

  Patient problems: Eczema; Hypersensitivity/Allergic reaction; Rash; Swelling; Swelling/ Edema

  MAUDE report 10713246 ↗
• InjuryOct 21, 2020Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT IS HAVING A POSSIBLE ALLERGIC REACTION TO SOME SPINAL IMPLANTS. THE INSTALLED IMPLANTS INCLUDE AN EPIC CONSTRUCT AND A BRECKENRIDGE CAGE. THE PATIENT IS ALLERGIC TO NICKEL AND MAY BE SENSITIVE TO COBALT CHROME. ALLERGY TESTS ARE ON-GOING AND A PLAN FOR CARE HAS NOT YET BEEN MADE. THIS IS REPORT SEVEN OF 14 FOR THIS EVENT.

  Patient problems: Eczema; Hypersensitivity/Allergic reaction; Rash; Swelling; Swelling/ Edema

  MAUDE report 10713200 ↗
• InjuryOct 21, 2020Malposition of Device; Biocompatibility; Migration; Malposition of Device; Biocompatibility; Migration

  IT WAS REPORTED THAT THE PATIENT IS HAVING A POSSIBLE ALLERGIC REACTION TO SOME SPINAL IMPLANTS. THE INSTALLED IMPLANTS INCLUDE AN EPIC CONSTRUCT AND A BRECKENRIDGE CAGE. THE PATIENT IS ALLERGIC TO NICKEL AND MAY BE SENSITIVE TO COBALT CHROME. ALLERGY TESTS ARE ON-GOING AND A PLAN FOR CARE HAS NOT YET BEEN MADE. THIS IS REPORT FIVE OF 14 FOR THIS EVENT.

  Patient problems: Eczema; Hypersensitivity/Allergic reaction; Rash; Swelling; Swelling/ Edema

  MAUDE report 10713193 ↗
• InjuryOct 21, 2020Biocompatibility; Migration; Biocompatibility; Migration

  IT WAS REPORTED THAT THE PATIENT IS HAVING A POSSIBLE ALLERGIC REACTION TO SOME SPINAL IMPLANTS. THE INSTALLED IMPLANTS INCLUDE A PEDICLE SCREW CONSTRUCT. THE PATIENT IS ALLERGIC TO NICKEL AND MAY BE SENSITIVE TO COBALT CHROME. ALLERGY TESTS ARE ON-GOING AND A PLAN FOR CARE HAS NOT YET BEEN MADE. THIS IS REPORT SIX OF 14 FOR THIS EVENT.

  Patient problems: Eczema; Hypersensitivity/Allergic reaction; Rash; Swelling; Swelling/ Edema

  MAUDE report 10713178 ↗