Vitality® 730M0017Recalls & reported problems
Biomet Spine LLC · Class 2
All models of Vitality (38)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00880304852761), received between Sep 11, 2020 and Jun 3, 2025 — classified as 1 injury, 13 malfunctions.
The most frequently reported specific device problem is “Fracture” (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. 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
- Fracture7
- Material Twisted/Bent4
- Material Deformation3
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information3
- No Consequences Or Impact To Patient2
- Foreign Body In Patient1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING INSPECTION OF A FIELD RETURN FROM A HOSPITAL, A WAREHOUSE DISCOVERED A FRACTURED TIP ON A VITAL T27 FINAL DRIVER. THE HOSPITAL DID NOT PROVIDE ANY PATIENT OR EVENT INFORMATION.
Patient problems: Insufficient Information
MAUDE report 22136065 ↗MalfunctionJan 29, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING INSPECTION OF A FIELD RETURN FROM A HOSPITAL, A WAREHOUSE DISCOVERED A VITAL T27 FINAL DRIVER WITH A TWISTED TIP. THE HOSPITAL DID NOT PROVIDE ANY PATIENT OR EVENT INFORMATION.
Patient problems: Insufficient Information
MAUDE report 21266610 ↗MalfunctionDec 11, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT A VITAL FINAL DRIVER TIP DEFORMED INTRA-OPERATIVELY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20907178 ↗MalfunctionDec 6, 2024Fracture; Fracture
A DISTRIBUTOR REPORTED THAT THEY DISCOVERED TWO VITAL T27 FINAL DRIVERS WITH DEFECTS DURING AN INSPECTION: ONE WITH A TWISTED TIP AND ONE WITH A FRACTURED TIP. THERE WAS NO REPORTED PATIENT IMPACT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20871339 ↗MalfunctionDec 6, 2024Material Deformation; Material Deformation
A DISTRIBUTOR REPORTED THAT THEY DISCOVERED TWO VITAL T27 FINAL DRIVERS WITH DEFECTS DURING AN INSPECTION: ONE WITH A TWISTED TIP AND ONE WITH A FRACTURED TIP. THERE WAS NO REPORTED PATIENT IMPACT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20870440 ↗InjurySep 5, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIPS OF TWO VITAL T27 FINAL DRIVERS FRACTURED DURING SURGERY AND A TORQUE LIMITING HANDLE TOOK MORE FORCE THAN USUAL TO TORQUE. THE FIRST BROKEN TIP OF THE SET SCREWDRIVER WAS RETRIEVED, BUT THE SECOND TIP REMAINED IN THE SET SCREW IN THE PATIENT BODY. A 30 MINUTE DELAY TO THE SURGERY WAS ALSO REPORTED. THIS IS REPORT TWO OF THREE FOR THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 20148555 ↗MalfunctionSep 5, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIPS OF TWO VITAL T27 FINAL DRIVERS FRACTURED DURING SURGERY AND A TORQUE LIMITING HANDLE TOOK MORE FORCE THAN USUAL TO TORQUE. THE FIRST BROKEN TIP OF THE SET SCREWDRIVER WAS RETRIEVED, BUT THE SECOND TIP REMAINED IN THE SET SCREW IN THE PATIENT BODY. A 30 MINUTE DELAY TO THE SURGERY WAS ALSO REPORTED. THIS IS REPORT ONE OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20148548 ↗MalfunctionMar 28, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE TIP OF A FINAL DRIVER WAS TWISTED, PREVENTING IT FROM MATING WITH A SCREW. THIS WAS FOUND DURING A ROUTINE INSPECTION SO THE INFORMATION RELATED TO THE EVENT OCCURRENCE IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18998712 ↗MalfunctionJan 25, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A SURGERY, THREE VITALITY DRIVERS FRACTURED WHEN TRYING TO REMOVE A STUCK ILIAC SCREW. THE SCREW WAS ULTIMATELY ABLE TO BE REMOVED AND REPLACED WITH A SHORTER SCREW. THIS RESULTED IN A 20 MINUTE DELAY TO THE PROCEDURE BUT NO OTHER PATIENT IMPACT. THIS IS REPORT ONE OF FOUR FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18584881 ↗MalfunctionJul 25, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT A FINAL DRIVER SHAFT WAS FOUND TO BE TWISTED AT THE TIP DURING INSPECTION. THERE WERE NO REPORTED PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17390721 ↗MalfunctionDec 21, 2022Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING SURGERY, A FINAL DRIVER TIP TWISTED. THERE WERE NO REPORTED PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16023590 ↗MalfunctionOct 21, 2022Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A VITAL T27 FINAL DRIVER BROKE OFF IN A SET SCREW WHILE ATTEMPTING TO REMOVE A PREVIOUSLY-PLACED CONSTRUCT. THEN A TAB ON THE TIP OF A ZYSTON STRAIGHT INLINE INSERTER BROKE OFF WHILE IT WAS BEING CONNECTED TO A PREVIOUSLY-PLACED CAGE. BOTH FRAGMENTS WERE RECOVERED FROM THE PATIENT AND ALTERNATIVE INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15655040 ↗MalfunctionSep 11, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING THE PROCEDURE TWO VITALITY DRIVERS WERE DEFORMED AND ONE DRIVER FRACTURED WHILE TRYING TO REMOVE A COMPETITORS SCREW SYSTEM. THERE WAS NO FURTHER SURGICAL INFORMATION PROVIDED AND NO ADDITIONAL PATIENT IMPACT REPORTED. THIS IS REPORT THREE OF THREE FOR THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10522208 ↗MalfunctionSep 11, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE TWO VITALITY DRIVERS WERE DEFORMED AND ONE DRIVER FRACTURED WHILE TRYING TO REMOVE A COMPETITORS SCREW SYSTEM. THERE WAS NO FURTHER SURGICAL INFORMATION PROVIDED AND NO ADDITIONAL PATIENT IMPACT REPORTED. THIS IS REPORT ONE OF THREE FOR THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10522201 ↗
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