Insignia 236-1-24018Recalls & reported problems
Alphatec Spine, Inc. · 4.0mm Variable Angle, Self-Drilling Screw, Single Lead 18mm · Class 2 · Implant
All models of Insignia (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00190376329796), received between Sep 22, 2022 and Apr 13, 2026 — classified as 3 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Material Protrusion/Extrusion1
Patient problems
- Failure of Implant5
- Post Operative Wound Infection1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗InjuryJun 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2023, A PATIENT UNDERWENT A 2-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C5-C7. ON (B)(6) 2023, DUE TO AN INFECTION AT THE SURGICAL SITE, THE PATIENT UNDERWENT AN INCISION AND DRAINAGE (I&D). DURING THE I&D PROCEDURE, THE SURGEON FOUND THE LEFT C7 SCREW BACKING OUT AND THE OVERLYING PORTION OF THE BLOCKER BENT, BUT STILL COVERING THE SCREW. THE BENT PORTION OF THE BLOCKER WAS BUMPED DURING SUCTION, CAUSING IT TO BREAK FREE FROM THE PLATE/BLOCKER ASSEMBLY. THE BROKEN PORTION WAS REMOVED FROM THE PATIENT. THE REMAINING PORTION OF THE BLOCKER, COVERING THE RIGHT-SIDE SCREW, ALONG WITH THE CENTRAL ATTACHMENT POINT OF THE BLOCKER TO THE PLATE REMAINED INTACT. THE LEFT C7 SCREW WAS REMOVED, THE WASH OUT WAS COMPLETED, AND THE SURGEON CLOSED THE WOUND.
Patient problems: Post Operative Wound Infection
MAUDE report 17159687 ↗InjurySep 24, 2022Fracture; Fracture
AT THE 6-WEEK POSTOPERATIVE VISIT, A RADIOGRAPH REVEALED A SCREW FRACTURE. REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE HARDWARE.
Patient problems: Failure of Implant
MAUDE report 15478529 ↗MalfunctionSep 22, 2022Device Dislodged or Dislocated; Material Protrusion/Extrusion; Device Dislodged or Dislocated; Material Protrusion/Extrusion
AT THE 3-MONTH POSTOPERATIVE VISIT, A RADIOGRAPH REVEALED A SCREW BACKOUT AT C6.
Patient problems: Failure of Implant
MAUDE report 15464996 ↗
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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.
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