IdentiTi 134-08181607-SRecalls & reported problems
Alphatec Spine, Inc. · IDENTITi CERVICAL SA SPACER, 8 x 18 x 16 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190376286402), received between Nov 14, 2025 and Nov 14, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
Patient problems
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT UNDERWENT A 1-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE ON (B)(6) 2025. ABOUT 6 MONTHS POSTOPERATIVELY, A RADIOGRAPHIC IMAGE REVEALED THAT THE LOCKING MECHANISM HAD FAILED CAUSING THE SCREW TO BACKOUT.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 23561676 ↗
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- NA 03.617.905Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical29 reports
- NA 03.617.904Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical27 reports
- Divergence® Anterior Cervical Fusion System G6626746Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical21 reports
- NA 03.647.972Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical17 reports
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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