VITALITY® 701M7550Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304867949), received between Oct 17, 2024 and Oct 17, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2024Loosening 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 SIX VITALITY CLOSURE TOPS THAT MIGRATED OUT OF THEIR MATING BONE SCREWS POST-OPERATIVELY. THE PATIENT HAD RECEIVED A T10-S2 POSTERIOR LUMBAR FUSION, AND THE CLOSURE TOPS POPPED OFF AT L5 TO S2. THE PATIENT CLAIMS THEY DID NOT FALL. THE REVISION WAS PERFORMED TO RE-INSTRUMENT USING LARGER SCREWS OF A DIFFERENT PRODUCT. THIS IS REPORT TEN OF TWELVE FOR THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 20472221 ↗
• InjuryOct 17, 2024Loosening 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 SIX VITALITY CLOSURE TOPS THAT MIGRATED OUT OF THEIR MATING BONE SCREWS POST-OPERATIVELY. THE PATIENT HAD RECEIVED A T10-S2 POSTERIOR LUMBAR FUSION, AND THE CLOSURE TOPS POPPED OFF AT L5 TO S2. THE PATIENT CLAIMS THEY DID NOT FALL. THE REVISION WAS PERFORMED TO RE-INSTRUMENT USING LARGER SCREWS OF A DIFFERENT PRODUCT. THIS IS REPORT NINE OF TWELVE FOR THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 20472219 ↗
• InjuryOct 17, 2024Loosening 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 SIX VITALITY CLOSURE TOPS THAT MIGRATED OUT OF THEIR MATING BONE SCREWS POST-OPERATIVELY. THE PATIENT HAD RECEIVED A T10-S2 POSTERIOR LUMBAR FUSION, AND THE CLOSURE TOPS POPPED OFF AT L5 TO S2. THE PATIENT CLAIMS THEY DID NOT FALL. THE REVISION WAS PERFORMED TO RE-INSTRUMENT USING LARGER SCREWS OF A DIFFERENT PRODUCT. THIS IS REPORT EIGHT OF TWELVE FOR THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 20472106 ↗
• InjuryOct 17, 2024Loosening 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 SIX VITALITY CLOSURE TOPS THAT MIGRATED OUT OF THEIR MATING BONE SCREWS POST-OPERATIVELY. THE PATIENT HAD RECEIVED A T10-S2 POSTERIOR LUMBAR FUSION, AND THE CLOSURE TOPS POPPED OFF AT L5 TO S2. THE PATIENT CLAIMS THEY DID NOT FALL. THE REVISION WAS PERFORMED TO RE-INSTRUMENT USING LARGER SCREWS OF A DIFFERENT PRODUCT. THIS IS REPORT SEVEN OF TWELVE FOR THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 20472064 ↗