VITALITY®+ POWER 731M0000Recalls & reported problems
Biomet Spine LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304854901), received between Jun 24, 2021 and Jun 3, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 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.
Reports received per month
Most reported problems
Device problems
- Material Deformation2
- Material Twisted/Bent2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2025Fracture; Fracture
A DISTRIBUTOR REPORTED THAT A VITALITY DRIVER WITH A FRACTURED TIP WAS DISCOVERED DURING PRE-INSPECTION. IT IS UNKNOWN WHEN THE DAMAGE OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22136181 ↗MalfunctionNov 6, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT TWO VITALITY DRIVER TIPS FROM A POWER SET BECAME TWISTED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT IMPACT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20623276 ↗MalfunctionNov 6, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT TWO VITALITY DRIVER TIPS FROM A POWER SET BECAME TWISTED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT IMPACT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20622242 ↗MalfunctionNov 16, 2021Material Deformation; Material Deformation
IT WAS REPORTED A DRIVER WAS FOUND WITH A DEFORMED TIP DURING A ROUTINE INSPECTION. IT IS UNKNOWN WHEN THE TIP BECAME DEFORMED.
Patient problems: Insufficient Information
MAUDE report 12824299 ↗MalfunctionJun 24, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT TWO FRACTURED SCREW INSERTERS, A DEFORMED PLUG DRIVER, AND A DEFORMED SCREWDRIVER ASSEMBLY WERE FOUND. THEY WERE DISCOVERED OUTSIDE OF SURGERY WITH NO PATIENT PRESENT. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12059496 ↗
Other Thoracolumbosacral pedicle screw system devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page