IdentiTi 132-10-85-300Recalls & reported problems
Alphatec Spine, Inc. · IdentiTi ALIF SA Graft Bolt, Ø8.5 x 30 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190376299730), received between Nov 19, 2021 and Aug 25, 2022 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (3 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.
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
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Failure of Implant1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2022Fracture; Fracture
ALPHATEC RECEIVED A MEDWATCH REPORT FROM THE HOSPITAL. PER THE REPORT, AN IMPLANTED SCREW BROKE INTO TWO PIECES. IMPLANTED HALF LEFT INSIDE THE PATIENT. THE EXPLANTED HALF WAS PLACED IN A CONTAINER AND SUBMITTED TO OR MANAGER (HALF SCREW LEFT IMPLANTED PER SURGEON FOR SAFETY).
Patient problems: Failure of Implant
MAUDE report 15298877 ↗InjuryMay 12, 2022Fracture; Fracture
ON (B)(6) 2022, AN IDENTITI ALIF SA GRAFT BOLT BROKE DURING INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14382238 ↗InjuryNov 19, 2021Fracture; Fracture
A POSTOPERATIVE RADIOGRAPH REVEALED A SA GRAFT BOLT FRACTURED. NO REVISION SURGERY PLANNED AT THIS TIME. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12849211 ↗
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
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page