IdentiTi 134-07141207-SRecalls & reported problems
Alphatec Spine, Inc. · IDENTITi CERVICAL SA SPACER, 7 x 14 x 12 mm, 7° · Class 2 · Implant
All models of IdentiTi (31)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190376286068), received between Nov 6, 2024 and Nov 6, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Material Separation1
Patient problems
- Device Embedded In Tissue or Plaque1
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 6, 2024Break; Material Separation; Break; Material Separation
AROUND 7-MONTHS POSTOPERATIVELY, A RADIOGRAPH IMAGE REVEALED THE LOCKING MECHANISM BROKE OFF FROM THE SPACER. IT IS SURROUNDED BY SCAR TISSUE AND REMAINS CONTAINED. THERE ARE NO PLANS FOR REVISION SURGERY. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant
MAUDE report 20623888 ↗
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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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