InsigniaRecalls & reported problems across all models
Alphatec Spine, Inc. · 34 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls
- 0
We found 34 models of Insignia by Alphatec Spine, Inc. in the FDA's device registry (GUDID). Together they are named in 54 adverse event reports in the FDA's MAUDE database, received between Mar 5, 2021 and Sep 18, 2026 — classified as 23 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (35 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 Insignia problems
Device problems
- Device Dislodged or Dislocated35
- Fracture9
- Break6
- Detachment of Device or Device Component4
- Material Separation3
- Device Slipped2
- Material Protrusion/Extrusion2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Failure of Implant29
- No Clinical Signs, Symptoms or Conditions15
- Insufficient Information11
- Neck Pain1
- Nonunion/Delayed-union Bone Fracture1
- Pain1
- Post Operative Wound Infection1
Insignia models
34 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Insignia 236-1-24018Appliance, fixation, spinal intervertebral body6 reports
- Insignia 436-0238Appliance, fixation, spinal intervertebral body5 reports
- Insignia 336-0356Appliance, fixation, spinal intervertebral body3 reports
- Insignia 436-0354Appliance, fixation, spinal intervertebral body3 reports
- Insignia 436-0478Appliance, fixation, spinal intervertebral body3 reports
- Insignia 236-1-24016Appliance, fixation, spinal intervertebral body2 reports
- Insignia 236-1-24022Appliance, fixation, spinal intervertebral body2 reports
- Insignia 436-0232Appliance, fixation, spinal intervertebral body2 reports
- Insignia 436-0360Appliance, fixation, spinal intervertebral body2 reports
- Insignia 436-0470Appliance, fixation, spinal intervertebral body2 reports
- Insignia 136-2-24014Appliance, fixation, spinal intervertebral body1 report
- Insignia 136-2-24016Appliance, fixation, spinal intervertebral body1 report
- Insignia 136-2-14014Appliance, fixation, spinal intervertebral body1 report
- Insignia 136-2-14016Appliance, fixation, spinal intervertebral body1 report
- Insignia 136-2-34014Appliance, fixation, spinal intervertebral body1 report
- Insignia 136-0236Appliance, fixation, spinal intervertebral body1 report
- Insignia 136-0242Appliance, fixation, spinal intervertebral body1 report
- Insignia 136-0121Appliance, fixation, spinal intervertebral body1 report
- Insignia 136-0358Appliance, fixation, spinal intervertebral body1 report
- Insignia 236-1-14014Appliance, fixation, spinal intervertebral body1 report
- Insignia 236-1-14016Appliance, fixation, spinal intervertebral body1 report
- Insignia 236-1-44016Appliance, fixation, spinal intervertebral body1 report
- Insignia 336-0236Appliance, fixation, spinal intervertebral body1 report
- Insignia 336-0240Appliance, fixation, spinal intervertebral body1 report
- Insignia 336-0360Appliance, fixation, spinal intervertebral body1 report
- Insignia 336-0364Appliance, fixation, spinal intervertebral body1 report
- Insignia 336-0466Appliance, fixation, spinal intervertebral body1 report
- Insignia 336-0478Appliance, fixation, spinal intervertebral body1 report
- Insignia 436-0118Appliance, fixation, spinal intervertebral body1 report
- Insignia 436-0119Appliance, fixation, spinal intervertebral body1 report
- Insignia 436-0234Appliance, fixation, spinal intervertebral body1 report
- Insignia 436-0244Appliance, fixation, spinal intervertebral body1 report
- Insignia 436-0352Appliance, fixation, spinal intervertebral body1 report
- Insignia 436-0356Appliance, fixation, spinal intervertebral body1 report
Recent Insignia adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829814 ↗MalfunctionJun 23, 2026Detachment of Device or Device Component
POSTOPERATIVE RADIOGRAPHIC IMAGING REVEALED A SCREW BACKING OUT OF THE PLATE. THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25598933 ↗MalfunctionJun 23, 2026Detachment of Device or Device Component
POSTOPERATIVE RADIOGRAPHIC IMAGING REVEALED A SCREW BACKING OUT OF THE PLATE. THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25598653 ↗MalfunctionMay 27, 2026Device Dislodged or Dislocated
A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE ON (B)(6) 2025. ABOUT 1 YEAR POSTOPERATIVELY, A RADIOGRAPHIC IMAGE REVEALED A SCREW BACKOUT AT THE MOST INFERIOR LEVEL. THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25310601 ↗MalfunctionMay 11, 2026Device Dislodged or Dislocated
A PATIENT UNDERWENT A 4-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE ON (B)(6) 2025. ABOUT 3 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGES REVEALED A SCREW BACKOUT AT THE MOST INFERIOR LEVEL. THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 25137441 ↗MalfunctionMay 5, 2026Device Dislodged or Dislocated
THE PATIENT UNDERWENT ACDFSPINAL PROCEDURE AT THE C6-7 LEVEL IN (B)(6) 2024. AROUND 12-MONTHS POSTOPERATIVELY, RADIOGRAPH IMAGING REVEALED A SCREW BACK OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25085865 ↗InjuryApr 15, 2026Break
A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION SPINAL PROCEDURE ON (B)(6) 2025. IT WAS REPORTED THAT TWO SCREWS BROKE POSTOPERATIVELY. REVISION SURGERY OCCURRED ON AN UNKNOWN DATE TO REMOVE THE TOP PORTION OF THE SCREWS AND FURTHER STABILIZE THE SPINE BY ADDING POSTERIOR FIXATION. THIS IS REPORT 2 OF 2.
Patient problems: Failure of Implant
MAUDE report 24888317 ↗InjuryApr 15, 2026Break
A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION SPINAL PROCEDURE ON (B)(6) 2025. IT WAS REPORTED THAT TWO SCREWS BROKE POSTOPERATIVELY. REVISION SURGERY OCCURRED ON AN UNKNOWN DATE TO REMOVE THE TOP PORTION OF THE SCREWS AND FURTHER STABILIZE THE SPINE BY ADDING POSTERIOR FIXATION. THIS IS REPORT 1 OF 2.
Patient problems: Failure of Implant
MAUDE report 24888015 ↗MalfunctionApr 14, 2026Device Dislodged or Dislocated
A PATIENT UNDERWENT A 2-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE ON NOVEMBER 4, 2025. AROUND 4 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGING REVEALED TWO SCREWS HAVE BACKED OUT OF THE PLATE. THE PATIENT IS BEING MONITORED.
Patient problems: Failure of Implant
MAUDE report 24877621 ↗InjuryApr 13, 2026Fracture
A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE ON (B)(6), 2025. IT WAS REPORTED THAT A SCREW BROKE 1 YEAR POSTOPERATIVELY. REVISION SURGERY IS PLANNED FOR (B)(6), 2026 TO REMOVE THE BROKEN SCREW.
Patient problems: Failure of Implant
MAUDE report 24865369 ↗MalfunctionApr 2, 2026Fracture
A PATIENT UNDERWENT A 2-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE ON (B)(6) 2025. ABOUT 4 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGES REVEALED THAT TWO SCREWS HAD FRACTURED. THIS IS REPORT 2 OF 2.
Patient problems: Insufficient Information
MAUDE report 24769109 ↗MalfunctionApr 2, 2026Fracture
A PATIENT UNDERWENT A 2-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE ON (B)(6) 2025. ABOUT 4 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGES REVEALED THAT TWO SCREWS HAD FRACTURED. THIS IS REPORT 1 OF 2.
Patient problems: Insufficient Information
MAUDE report 24769080 ↗MalfunctionMar 31, 2026Device Dislodged or Dislocated
A PATIENT UNDERWENT A 3-LEVEL ANTERIOR CERVICAL AND DISCECTOMY FUSION PROCEDURE ON (B)(6) 2025. ABOUT 6 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGES REVEALED THAT TWO SUPERIOR SCREWS HAD FRACTURED, AND 1 INFERIOR SCREW HAD BEGUN TO BACKOUT OF THE PLATE. THERE ARE NO PLANS FOR REVISION SURGERY. THIS IS REPORT 3 OF 3.
Patient problems: Failure of Implant
MAUDE report 24746127 ↗MalfunctionMar 31, 2026Fracture
A PATIENT UNDERWENT A 3-LEVEL ANTERIOR CERVICAL AND DISCECTOMY FUSION PROCEDURE ON (B)(6) 2025. ABOUT 6 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGES REVEALED THAT TWO SUPERIOR SCREWS HAD FRACTURED, AND 1 INFERIOR SCREW HAD BEGUN TO BACKOUT OF THE PLATE. THERE ARE NO PLANS FOR REVISION SURGERY. THIS IS REPORT 2 OF 3.
Patient problems: Failure of Implant
MAUDE report 24746098 ↗MalfunctionMar 31, 2026Fracture
A PATIENT UNDERWENT A 3-LEVEL ANTERIOR CERVICAL AND DISCECTOMY FUSION PROCEDURE ON (B)(6) 2025. ABOUT 6 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGES REVEALED THAT TWO SUPERIOR SCREWS HAD FRACTURED, AND 1 INFERIOR SCREW HAD BEGUN TO BACKOUT OF THE PLATE. THERE ARE NO PLANS FOR REVISION SURGERY. THIS IS REPORT 1 OF 3.
Patient problems: Failure of Implant
MAUDE report 24746054 ↗
Other Alphatec Spine, Inc. products
- Invictus96 models · 448 reports
- IdentiTi31 models · 68 reports · 1 recall
- ATEC Lateral Navigation Disc Prep Instruments2 models · 0 reports · 2 recalls
- Calibrate44 models · 40 reports · 1 recall
- Arsenal18 models · 86 reports
- Illico20 models · 69 reports
- AMP5 models · 4 reports · 1 recall
- Trestle Luxe24 models · 38 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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