IdentiTi 232-10-85-350Recalls & reported problems
Alphatec Spine, Inc. · IdentiTi ALIF SA Graft Bolt, Ø8.5 x 35 mm · Class 2 · Implant
All models of IdentiTi (31)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190376370019), received between Aug 7, 2022 and Sep 29, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Jan 26, 2024Class IIOpen, Classified
Due to reports of intraoperative graft bolt implantation breakages.
Z-1182-2024 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2022Fracture; Fracture
IT WAS REPORTED THE SURGEON APPLIED TOO MUCH TORQUE ON THE DRIVER CAUSING THE GRAFT BOLT TO FRACTURE DURING INSERTION. A PORTION OF THE GRAFT BOLT REMAINS IN THE PATIENT.
Patient problems: Failure of Implant
MAUDE report 15508547 ↗MalfunctionAug 7, 2022Break; Break
AFTER INSERTING A SCREW, THE SURGEON DECIDED TO USE A LONGER ONE. THE SHORT SCREW WAS REMOVED ALONG WITH SOME BONE; THE LONGER SCREW SHEARED ONCE THE DISTAL PORTION ENGAGED THE BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15180711 ↗
Other Intervertebral fusion device with integrated fixation, lumbar devices
- PIVOX™ Oblique Lateral Spinal System 2161001Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, lumbar182 reports
- IdentiTi 232-10-85-300Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall8 reports
- IdentiTi 232-10-85-250Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall5 reports
- IdentiTi 132-10-85-300Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall3 reports
- MectaLIF Anterior 03.30.301Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall2 reports
- IdentiTi 232-11-90-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall1 report
- MectaLIF Anterior 03.30.302Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall1 report
- MectaLIF Anterior 03.30.300Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall1 report
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 · each recall links to the FDA recall notice
- 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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