VITALITY® 701M6545Recalls & reported problems
Biomet Spine LLC · Class 2
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304867512), received between Jan 2, 2025 and Jan 2, 2025 — classified as 7 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (7 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.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth7
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
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 FOURTEEN OF FOURTEEN FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21063028 ↗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 THIRTEEN OF FOURTEEN FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21063024 ↗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 TWELVE OF FOURTEEN FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21063005 ↗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 ELEVEN OF FOURTEEN FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21062555 ↗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 TEN OF FOURTEEN FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21062442 ↗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 NINE OF FOURTEEN FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21062262 ↗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 EIGHT OF FOURTEEN FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21062054 ↗
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- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.