VITALITY® 709M8555Recalls & reported problems
Biomet Spine LLC · Class 2
All models of Vitality (38)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304868373), received between Feb 27, 2020 and Feb 14, 2025 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Fracture2
Patient problems
- No Known Impact Or Consequence To Patient3
- Pain2
- Ambulation or Postural Difficulties1
- Cramp(s) /Muscle Spasm(s)1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryFeb 14, 2025Fracture; Fracture
IT WAS REPORTED THAT A PEDICLE SCREW AT RIGHT S1 WAS DISCOVERED TO BE FRACTURED DURING AN X-RAY APPROXIMATELY 7 MONTHS POST-OPERATIVELY. THE PATIENT REPORTS PAIN, CRAMPS, AND DIFFICULTY STANDING STRAIGHT. A REVISION SURGERY HAS NOT YET BEEN SCHEDULED GIVEN THAT FUSION APPEARS TO BE OCCURRING AND THE BROKEN SCREW IS NOT CAUSING NERVE COMPRESSION. THE PATIENT IS BEING MONITORED.
Patient problems: Ambulation or Postural Difficulties; Cramp(s) /Muscle Spasm(s); Pain
MAUDE report 21386018 ↗InjuryOct 3, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO REPLACE TWO VITALITY SCREWS THAT FRACTURED DURING A CAR ACCIDENT. THE PATIENT WAS EXPERIENCING PAIN, AND THE SCREWS WERE REMOVED AND REPLACED WITH LARGER SCREWS AT THE S1 VERTEBRA. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: Pain
MAUDE report 20363665 ↗MalfunctionFeb 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE PROCEDURE THREE SCREWS DISASSEMBLED WHILE BEING INSERTED. TWO OF THE SCREWS WERE INSERTED WITH A POWER DRILL AND THE THIRD WITH A RATCHET HANDLE. THEY WERE REMOVED AND REPLACED WITH ALTERNATE SCREWS TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT HARM. THIS IS REPORT THREE OF THREE FOR THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9766214 ↗MalfunctionFeb 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE PROCEDURE THREE SCREWS DISASSEMBLED WHILE BEING INSERTED. TWO OF THE SCREWS WERE INSERTED WITH A POWER DRILL AND THE THIRD WITH A RATCHET HANDLE. THEY WERE REMOVED AND REPLACED WITH ALTERNATE SCREWS TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT HARM. THIS IS REPORT TWO OF THREE FOR THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9766186 ↗MalfunctionFeb 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE PROCEDURE THREE SCREWS DISASSEMBLED WHILE BEING INSERTED. TWO OF THE SCREWS WERE INSERTED WITH A POWER DRILL AND THE THIRD WITH A RATCHET HANDLE. THEY WERE REMOVED AND REPLACED WITH ALTERNATE SCREWS TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT HARM.THIS IS REPORT ONE OF THREE FOR THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9766019 ↗
Other Appliance, fixation, spinal intervertebral body devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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