IdentiTi 232-10-85-250Recalls & reported problems
Alphatec Spine, Inc. · IdentiTi ALIF SA Graft Bolt, Ø8.5 x 25 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
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00190376369976), received between Dec 2, 2021 and Aug 26, 2025 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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.
Reports received per month
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
- Break2
- Fracture2
- Device Damaged by Another Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Failure of Implant2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2025Break; Break
A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE ON (B)(6) 2025. IT WAS REPORTED THAT DURING THE PROCEDURE, THE GRAFT BOLT BROKE WHEN BEING IMPLANTED INTO THE L5 VERTEBRA. APPROXIMATELY HALF OF THE BOLT WAS LEFT IN THE CAGE AND VERTEBRA.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 22899023 ↗MalfunctionMay 28, 2025Device Damaged by Another Device; Device Damaged by Another Device
A PATIENT UNDERWENT AN ANTERIOR LUMBER INTERBODY FUSION PROCEDURE AT THE L4-L5 LEVEL. FOLLOWING SPACER PLACEMENT AND HOLE PREPARATION, THE GRAFT BOLT WAS INSERTED BUT ADVANCED THROUGH THE SPACER, BYPASSING THE LOCKING MECHANISM.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 22100663 ↗MalfunctionDec 19, 2023Break; Break
DURING AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE, THE GRAFT BOLT BROKE IN TWO WHEN THE SURGEON WAS TIGHTENING. THE HEAD OF THE SCREW WAS RECOVERED, BUT THE SHANK REMAINS IN SITU. THERE ARE NO PLANS FOR REVISION SURGERY. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18360621 ↗MalfunctionMay 24, 2022Fracture; Fracture
DURING SURGERY, THE TOP PORTION OF A GRAFT BOLT BROKE OFF WHEN THE SURGEON WAS TRYING TO SCREW IT INTO THE SPACER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14493070 ↗InjuryDec 2, 2021Fracture; Fracture
ON (B)(6) 2021, A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION SURGERY. IT WAS REPORTED THE GRAFT BOLT FRACTURED WHILE BEING INSERTED INTO THE SPACER. THE BROKEN TOP PORTION OF THE BOLT WAS REMOVED AND DISCARDED BY THE HOSPITAL. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12921151 ↗
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 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 232-10-85-350Alphatec Spine, Inc. · 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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