IdentiTi 120-08093010-SRecalls & reported problems
Alphatec Spine, Inc. · IDENTITi PS POROUS Ti SPACER, 8 x 9 x 30 mm, 10° · 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 00190376193670), received between Apr 30, 2025 and Apr 30, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Unintended Movement” (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
- Unintended Movement1
Patient problems
- 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.
InjuryApr 30, 2025Unintended Movement; Unintended Movement
A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2024. APPROXIMATELY TWO AND A HALF MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGING REVEALED THAT THE ROD ON THE RIGHT SIDE OF THE CONSTRUCT HAD COMPLETELY DISENGAGED FROM THE TULIP HEAD, AND THE INTERBODY IMPLANT HAD ROTATED WITHIN THE DISC SPACE. DURING REVISION SURGERY, EXPOSURE OF THE ORIGINAL CONSTRUCT REVEALED ALL SET SCREWS WERE INTACT AND SECURE ON THE ROD EXCEPT FOR THE RIGHT L4 SCREW. ALTHOUGH THE SET SCREW REMAINED SEATED WITHIN THE TULIP HEAD, THE ROD HAD MIGRATED OUT OF POSITION. BOTH RODS WERE SUBSEQUENTLY REMOVED AND REPLACED, ALONG WITH THE SCREWS AT L4 AND L2. ALL SET SCREWS WERE ALSO REMOVED AND REPLACED. PRIOR TO FINAL TIGHTENING, THE INTERBODY IMPLANT WAS REPOSITIONED. THIS REPORT 2 OF 2.
Patient problems: Failure of Implant
MAUDE report 21939650 ↗
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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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