VitalRecalls & reported problems across all models

We found 30 models of Vital by Biomet Spine LLC in the FDA's device registry (GUDID). Together they are named in 12 adverse event reports in the FDA's MAUDE database, received between Sep 14, 2021 and Oct 17, 2024 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 reports).

24 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Vital recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 5, 2020Class IITerminated

   There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

   Z-2234-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 5, 2020Class IITerminated

   There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

   Z-2232-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. May 5, 2020Class IITerminated

   There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

   Z-2231-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. May 5, 2020Class IITerminated

   There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

   Z-2230-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. May 5, 2020Class IITerminated

   There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

   Z-2229-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. May 5, 2020Class IITerminated

   There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

   Z-2228-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. May 5, 2020Class IITerminated

   There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

   Z-2227-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

8. May 5, 2020Class IITerminated

   There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

   Z-2226-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

9. May 5, 2020Class IITerminated

   There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

   Z-2225-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

10. May 5, 2020Class IITerminated

    There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

    Z-2224-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

11. May 5, 2020Class IITerminated

    There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

    Z-2223-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

12. May 5, 2020Class IITerminated

    There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

    Z-2222-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

13. May 5, 2020Class IITerminated

    There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

    Z-2221-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

14. May 5, 2020Class IITerminated

    There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

    Z-2220-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

15. May 5, 2020Class IITerminated

    There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

    Z-2219-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

16. May 5, 2020Class IITerminated

    There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

    Z-2218-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

17. May 5, 2020Class IITerminated

    There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

    Z-2217-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

18. May 5, 2020Class IITerminated

    There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

    Z-2216-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

19. May 5, 2020Class IITerminated

    There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

    Z-2215-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

20. May 5, 2020Class IITerminated

    There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

    Z-2214-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

21. May 5, 2020Class IITerminated

    There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

    Z-2213-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

22. May 5, 2020Class IITerminated

    There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

    Z-2212-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

23. May 5, 2020Class IITerminated

    There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

    Z-2211-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

24. May 5, 2020Class IITerminated

    There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

    Z-2210-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Vital problems

Vital models

30 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Vital™ 810M4530

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 810M4535

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 810M4540

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 810M4545

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 810M5535

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 810M5540

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 810M5545

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 810M5550

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 810M5555

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 810M6535

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 810M6540

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 810M6545

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 810M6550

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 810M6555

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 810M7535

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 810M7540

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 810M7545

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 810M7550

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 810M7555

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 811M8540

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 811M8545

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 811M8550

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 811M8555

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 811M8560

  Thoracolumbosacral pedicle screw system
  1 recall0 reports
• Vital™ 801M4545

  Thoracolumbosacral pedicle screw system
  6 reports
• Vital™ 801M5545

  Thoracolumbosacral pedicle screw system
  2 reports
• Vital™ 801M5540

  Thoracolumbosacral pedicle screw system
  1 report
• Vital™ 850M0022

  Screwdriver
  1 report
• Vital™ 850M0025

  Screwdriver
  1 report
• Vital™ 805M8570

  Thoracolumbosacral pedicle screw system
  1 report

Recent Vital adverse event reports

The 12 most recent reports across all models, 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 ELEVEN OF TWELVE FOR THIS EVENT.

  Patient problems: Failure of Implant

  MAUDE report 20472155 ↗
• MalfunctionOct 15, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A DISTRIBUTOR DISCOVERED A VITAL MIS DRIVER WITH A TWISTED TIP DURING A ROUTINE INSPECTION. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453295 ↗
• InjuryAug 7, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A T10-PELVIS REVISION SURGERY WAS CONDUCTED TO CORRECT SIX VITALITY SCREWS THAT WERE FOUND TO HAVE FRACTURED OR BENT POST-OPERATIVELY. NO FURTHER INFORMATION REGARDING PATIENT IMPACT OR REVISION TYPE IS AVAILABLE AT THIS TIME. THIS IS REPORT SIX OF SIX FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19933897 ↗
• InjuryAug 7, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A T10-PELVIS REVISION SURGERY WAS CONDUCTED TO CORRECT SIX VITALITY SCREWS THAT WERE FOUND TO HAVE FRACTURED OR BENT POST-OPERATIVELY. NO FURTHER INFORMATION REGARDING PATIENT IMPACT OR REVISION TYPE IS AVAILABLE AT THIS TIME.THIS IS REPORT FIVE OF SIX FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19933894 ↗
• InjuryAug 7, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A T10-PELVIS REVISION SURGERY WAS CONDUCTED TO CORRECT SIX VITALITY SCREWS THAT WERE FOUND TO HAVE FRACTURED OR BENT POST-OPERATIVELY. NO FURTHER INFORMATION REGARDING PATIENT IMPACT OR REVISION TYPE IS AVAILABLE AT THIS TIME. THIS IS REPORT FOUR OF SIX FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19933891 ↗
• InjuryAug 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT A T10-PELVIS REVISION SURGERY WAS CONDUCTED TO CORRECT SIX VITALITY SCREWS THAT WERE FOUND TO HAVE FRACTURED OR BENT POST-OPERATIVELY. NO FURTHER INFORMATION REGARDING PATIENT IMPACT OR REVISION TYPE IS AVAILABLE AT THIS TIME. THIS IS REPORT THREE OF SIX FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19933876 ↗
• InjuryAug 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT A T10-PELVIS REVISION SURGERY WAS CONDUCTED TO CORRECT SIX VITALITY SCREWS THAT WERE FOUND TO HAVE FRACTURED OR BENT POST-OPERATIVELY. NO FURTHER INFORMATION REGARDING PATIENT IMPACT OR REVISION TYPE IS AVAILABLE AT THIS TIME. THIS IS REPORT TWO OF SIX FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19933869 ↗
• InjuryAug 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT A T10-PELVIS REVISION SURGERY WAS CONDUCTED TO CORRECT SIX VITALITY SCREWS THAT WERE FOUND TO HAVE FRACTURED OR BENT POST-OPERATIVELY. NO FURTHER INFORMATION REGARDING PATIENT IMPACT OR REVISION TYPE IS AVAILABLE AT THIS TIME. THIS IS REPORT ONE OF SIX FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19933864 ↗
• MalfunctionMay 24, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT A VITAL MIS DRIVER STRIPPED INTRA-OPERATIVELY. THE SURGERY WAS COMPLETED WITH ANOTHER DRIVER. THERE ARE NO ADVERSE EVENTS OR PATIENT IMPACTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16994408 ↗
• InjurySep 14, 2021Fracture; Fracture

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED TO ADDRESS POST-OP SCREW BREAKAGE AND MALUNION. PRIOR TO THE REVISION, THE SURGEON THOUGHT ONE SCREW WAS BROKEN, BUT THREE SCREWS WERE FOUND TO BE BROKEN DURING THE REVISION. THE SHAFTS OF THE THREE SCREWS WERE UNABLE TO BE REMOVED AND REMAIN IMPLANTED WITHIN THE PATIENT. NO NEW HARDWARE WAS ADDED DURING THE REVISION. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

  Patient problems: Foreign Body In Patient; Malunion of Bone

  MAUDE report 12470947 ↗
• InjurySep 14, 2021Fracture; Fracture

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED TO ADDRESS POST-OP SCREW BREAKAGE AND MALUNION. PRIOR TO THE REVISION, THE SURGEON THOUGHT ONE SCREW WAS BROKEN, BUT THREE SCREWS WERE FOUND TO BE BROKEN DURING THE REVISION. THE SHAFTS OF THE THREE SCREWS WERE UNABLE TO BE REMOVED AND REMAIN IMPLANTED WITHIN THE PATIENT. NO NEW HARDWARE WAS ADDED DURING THE REVISION. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

  Patient problems: Foreign Body In Patient; Malunion of Bone

  MAUDE report 12470943 ↗
• InjurySep 14, 2021Fracture; Fracture

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED TO ADDRESS POST-OP SCREW BREAKAGE AND MALUNION. PRIOR TO THE REVISION, THE SURGEON THOUGHT ONE SCREW WAS BROKEN, BUT THREE SCREWS WERE FOUND TO BE BROKEN DURING THE REVISION. THE SHAFTS OF THE THREE SCREWS WERE UNABLE TO BE REMOVED AND REMAIN IMPLANTED WITHIN THE PATIENT. NO NEW HARDWARE WAS ADDED DURING THE REVISION. THIS IS REPORT TWO OF THREE FOR THIS EVENT.

  Patient problems: Foreign Body In Patient; Malunion of Bone

  MAUDE report 12470909 ↗

Other Biomet Spine LLC products

• Vitality38 models · 157 reports · 4 recalls
• POLARIS 5.5 SPINAL SYSTEM17 models · 74 reports
• Vital MIS Spinal Fixation System11 models · 25 reports