IdentiTi 134-07161407-SRecalls & reported problems
Alphatec Spine, Inc. · IDENTITi CERVICAL SA SPACER, 7 x 16 x 14 mm, 7° · Class 2 · Implant
All models of IdentiTi (31)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190376286129), received between Oct 17, 2024 and Nov 13, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Material Separation2
- Device Dislodged or Dislocated1
Patient problems
- Failure of Implant3
- Dysphagia/ Odynophagia1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT UNDERWENT A 2-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE ON (B)(6) 2025. AROUND 6 MONTHS POSTOPERATIVELY, A RADIOGRAPHIC IMAGE REVEALED THAT THE LOCKING MECHANISM HAD FAILED CAUSING THE SCREW TO BACKOUT. THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 23545302 ↗InjuryNov 6, 2024Break; Material Separation; Break; Material Separation
AROUND 7-MONTHS POSTOPERATIVELY, RADIOGRAPH IMAGES REVEALED THE LOCKING MECHANISM BROKE OFF FROM THE SPACER AT THE C6/C7 LEVEL. IT IS CONTAINED WITHIN THE BONE. THERE ARE NO PLANS FOR REVISION. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT.
Patient problems: Failure of Implant
MAUDE report 20622694 ↗InjuryOct 17, 2024Break; Material Separation; Break; Material Separation
AROUND THREE MONTHS AFTER SURGERY, THE PATIENT REPORTED EXPERIENCING PAIN WHILE SWALLOWING. A RADIOGRAPH WAS PERFORMED, WHICH SHOWED THAT THE BLOCKER ON THE SPACER HAD BECOME UNLOCKED AND WAS BACKING OUT. REVISION SURGERY WAS PERFORMED.
Patient problems: Dysphagia/ Odynophagia; Failure of Implant
MAUDE report 20475615 ↗
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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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