Vital MIS Spinal Fixation SystemRecalls & reported problems across all models
Biomet Spine LLC · 11 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 0
We found 11 models of Vital MIS Spinal Fixation System by Biomet Spine LLC in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Dec 17, 2021 and Oct 15, 2025 — classified as 18 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (18 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. 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
Reports received per month, all models
Most reported Vital MIS Spinal Fixation System problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth18
- Fracture5
- Detachment of Device or Device Component1
- Device-Device Incompatibility1
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Pain5
- Failure of Implant2
- Insufficient Information2
- Swelling/ Edema2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body In Patient1
Vital MIS Spinal Fixation System models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Vital™ MIS Spinal Fixation System 824M6545Thoracolumbosacral pedicle screw system11 reports
- Vital™ MIS Spinal Fixation System 850M0078SCREWDRIVER2 reports
- Vital™ MIS Spinal Fixation System 824M6540Thoracolumbosacral pedicle screw system2 reports
- Vital™ MIS Spinal Fixation System 824M6550Thoracolumbosacral pedicle screw system2 reports
- Vital™ MIS Spinal Fixation System 824M7545Thoracolumbosacral pedicle screw system2 reports
- Vital™ MIS Spinal Fixation System 850M5045Thoracolumbosacral pedicle screw system1 report
- Vital™ MIS Spinal Fixation System 850M6045Thoracolumbosacral pedicle screw system1 report
- Vital™ MIS Spinal Fixation System 824M5545Thoracolumbosacral pedicle screw system1 report
- Vital™ MIS Spinal Fixation System 824M7535Thoracolumbosacral pedicle screw system1 report
- Vital™ MIS Spinal Fixation System 824M7550Thoracolumbosacral pedicle screw system1 report
- Vital™ MIS Spinal Fixation System 824M7555Thoracolumbosacral pedicle screw system1 report
Recent Vital MIS Spinal Fixation System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT A VITAL MIS SCREW HEAD BROKE OFF DURING IMPLANT REMOVAL SURGERY. IMPLANT REMOVAL WAS PERFORMED BECAUSE THE CLOSURE TOP HAD COME OFF AND FUSION WAS COMPLETED. THERE WAS NO PATIENT HARM OR PROCEDURAL DELAY. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23304811 ↗MalfunctionJul 9, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING INSPECTION, IT WAS DISCOVERED THAT THE TIP OF THE VITAL T27 DRIVER WAS DAMAGED AND THAT IT WOULD NO LONGER HOLD THE CAPS. THERE WAS NO REPORTED PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22460370 ↗InjuryMar 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A WEEK POST-OPERATIVELY, A CLOSURE TOP MIGRATED OUT OF ITS MATING PEDICLE SCREW. A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE BOTH THE CLOSURE TOP AND SCREW. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21634574 ↗InjuryMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT TWO VITAL MIS SET SCREWS MIGRATED FROM THEIR MATING POLYAXIAL PEDICLE SCREWS POST-OPERATIVELY. THIS WAS DISCOVERED APPROXIMATELY TWO WEEKS POST-OP VIA X-RAY. THE PATIENT IS CURRENTLY ASYMPTOMATIC BUT THE SURGEON IS PLANNING TO REVISE THE CONSTRUCT. THE SURGEON BELIEVES THAT THE TORQUE HANDLE USED DID NOT PROVIDE ADEQUATE TORQUE. THIS IS REPORT THREE OF FIVE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21588344 ↗InjuryMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT TWO VITAL MIS SET SCREWS MIGRATED FROM THEIR MATING POLYAXIAL PEDICLE SCREWS POST-OPERATIVELY. THIS WAS DISCOVERED APPROXIMATELY TWO WEEKS POST-OP VIA X-RAY. THE PATIENT IS CURRENTLY ASYMPTOMATIC BUT THE SURGEON IS PLANNING TO REVISE THE CONSTRUCT. THE SURGEON BELIEVES THAT THE TORQUE HANDLE USED DID NOT PROVIDE ADEQUATE TORQUE. THIS IS REPORT ONE OF FIVE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21588213 ↗InjuryMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT FOUR VITAL MIS SET SCREWS MIGRATED FROM THEIR MATING POLYAXIAL PEDICLE SCREWS POST-OPERATIVELY. THIS WAS DISCOVERED APPROXIMATELY TWO WEEKS POST-OP VIA X-RAY. THE PATIENT IS CURRENTLY ASYMPTOMATIC BUT THE SURGEON IS PLANNING TO REVISE THE CONSTRUCT. THE SURGEON BELIEVES THAT THE TORQUE HANDLE USED DID NOT PROVIDE ADEQUATE TORQUE. THIS IS REPORT EIGHT OF NINE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21587806 ↗InjuryMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT FOUR VITAL MIS SET SCREWS MIGRATED FROM THEIR MATING POLYAXIAL PEDICLE SCREWS POST-OPERATIVELY. THIS WAS DISCOVERED APPROXIMATELY TWO WEEKS POST-OP VIA X-RAY. THE PATIENT IS CURRENTLY ASYMPTOMATIC BUT THE SURGEON IS PLANNING TO REVISE THE CONSTRUCT. THE SURGEON BELIEVES THAT THE TORQUE HANDLE USED DID NOT PROVIDE ADEQUATE TORQUE. THIS IS REPORT SIX OF NINE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21587697 ↗InjuryMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT FOUR VITAL MIS SET SCREWS MIGRATED FROM THEIR MATING POLYAXIAL PEDICLE SCREWS POST-OPERATIVELY. THIS WAS DISCOVERED APPROXIMATELY TWO WEEKS POST-OP VIA X-RAY. THE PATIENT IS CURRENTLY ASYMPTOMATIC BUT THE SURGEON IS PLANNING TO REVISE THE CONSTRUCT. THE SURGEON BELIEVES THAT THE TORQUE HANDLE USED DID NOT PROVIDE ADEQUATE TORQUE. THIS IS REPORT FOUR OF NINE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21587685 ↗InjuryMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT FOUR VITAL MIS SET SCREWS MIGRATED FROM THEIR MATING POLYAXIAL PEDICLE SCREWS POST-OPERATIVELY. THIS WAS DISCOVERED APPROXIMATELY TWO WEEKS POST-OP VIA X-RAY. THE PATIENT IS CURRENTLY ASYMPTOMATIC BUT THE SURGEON IS PLANNING TO REVISE THE CONSTRUCT. THE SURGEON BELIEVES THAT THE TORQUE HANDLE USED DID NOT PROVIDE ADEQUATE TORQUE. THIS IS REPORT TWO OF NINE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21587665 ↗InjuryMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT TWO VITAL MIS SET SCREWS MIGRATED FROM THEIR MATING POLYAXIAL PEDICLE SCREWS POST-OPERATIVELY. THIS WAS DISCOVERED APPROXIMATELY TWO WEEKS POST-OP VIA X-RAY. THE PATIENT IS CURRENTLY ASYMPTOMATIC BUT THE SURGEON IS PLANNING TO REVISE THE CONSTRUCT. THE SURGEON BELIEVES THAT THE TORQUE HANDLE USED DID NOT PROVIDE ADEQUATE TORQUE.THIS IS REPORT FOUR OF FIVE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21586651 ↗InjuryMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT TWO VITAL MIS SET SCREWS MIGRATED FROM THEIR MATING POLYAXIAL PEDICLE SCREWS POST-OPERATIVELY. THIS WAS DISCOVERED APPROXIMATELY TWO WEEKS POST-OP VIA X-RAY. THE PATIENT IS CURRENTLY ASYMPTOMATIC BUT THE SURGEON IS PLANNING TO REVISE THE CONSTRUCT. THE SURGEON BELIEVES THAT THE TORQUE HANDLE USED DID NOT PROVIDE ADEQUATE TORQUE. THIS IS REPORT TWO OF FIVE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21586629 ↗MalfunctionFeb 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A SPINAL FUSION PATIENT WAS FOUND TO HAVE TWO CLOSURE TOPS AT L3 AND L5 THAT MIGRATED OUT OF THEIR MATING PEDICLE SCREWS. THIS WAS DISCOVERED VIA X-RAY DURING A FOLLOW-UP APPOINTMENT APPROXIMATELY THREE WEEKS POST-OPERATIVELY. THE PATIENT IS ASYMPTOMATIC AND IS CONSULTING WITH THEIR SURGEON TO DETERMINE IF A REVISION IS NECESSARY. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21472981 ↗MalfunctionFeb 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A SPINAL FUSION PATIENT WAS FOUND TO HAVE TWO CLOSURE TOPS AT L3 AND L5 THAT MIGRATED OUT OF THEIR MATING PEDICLE SCREWS. THIS WAS DISCOVERED VIA X-RAY DURING A FOLLOW-UP APPOINTMENT APPROXIMATELY THREE WEEKS POST-OPERATIVELY. THE PATIENT IS ASYMPTOMATIC AND IS CONSULTING WITH THEIR SURGEON TO DETERMINE IF A REVISION IS NECESSARY. THIS IS REPORT THREE OF FOUR FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21472963 ↗InjuryNov 22, 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 ON A VITAL MIS PATIENT TO ADDRESS PAIN FIVE DAYS AFTER THE INITIAL SURGERY. FOLLOW-UP X-RAYS REVEALED A HEMATOMA AS WELL AS A MIGRATED SET SCREW AND A LOOSE SET SCREW ON THE RIGHT SIDE OF THE CONSTRUCT. SEVEN DAYS POST-OPERATIVELY, THE REVISION SURGERY WAS PERFORMED AND THE ENTIRE RIGHT SIDE OF THE CONSTRUCT WAS REMOVED AND REPLACED. THE LEFT SIDE OF THE CONSTRUCT WAS CHECKED AND FOUND TO HAVE NO PROBLEMS. THIS IS REPORT ONE OF FOUR FOR THIS EVENT.
Patient problems: Pain; Swelling/ Edema
MAUDE report 20765201 ↗InjuryNov 22, 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 ON A VITAL MIS PATIENT TO ADDRESS PAIN FIVE DAYS AFTER THE INITIAL SURGERY. FOLLOW-UP X-RAYS REVEALED A HEMATOMA AS WELL AS A MIGRATED SET SCREW AND A LOOSE SET SCREW ON THE RIGHT SIDE OF THE CONSTRUCT. SEVEN DAYS POST-OPERATIVELY, THE REVISION SURGERY WAS PERFORMED AND THE ENTIRE RIGHT SIDE OF THE CONSTRUCT WAS REMOVED AND REPLACED. THE LEFT SIDE OF THE CONSTRUCT WAS CHECKED AND FOUND TO HAVE NO PROBLEMS. THIS IS REPORT THREE OF FOUR FOR THIS EVENT.
Patient problems: Pain; Swelling/ Edema
MAUDE report 20761844 ↗
Other Biomet Spine LLC products
All Biomet Spine LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
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