IdentiTi 233-150Recalls & reported problems
Alphatec Spine, Inc. · IdentiTi ALIF SA, Inserter, Anterolateral · Class 2 · Implant
All models of IdentiTi (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Alphatec Spine IdentiTi inserter is a surgical tool used to place spinal implants during lumbar fusion. Most of the 28 reports describe the plastic prong or tip snapping off or breaking, either during insertion or while being removed, sometimes leaving a piece behind in the patient that then has to be retrieved. There are no deaths and 2 injuries. No recalls name this device. Reports dropped sharply, from 11 in the earlier 12 months to 1 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00190376382982), received between Oct 16, 2023 and Sep 8, 2026 — classified as 3 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Material Separation” (21 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation21
- Break14
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- Foreign Body In Patient3
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2026Break; Material Separation
Patient problems: Foreign Body In Patient
MAUDE report 50678990 ↗MalfunctionMar 11, 2026Break; Material Separation
IT WAS REPORTED THAT THE PRONG OF THE INSERTER SNAPPED OFF DURING A CASE. THE PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24571731 ↗MalfunctionSep 17, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT A PIECE OF THE INSERTER BROKE OFF DURING A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23074744 ↗MalfunctionSep 4, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE INSERTER BROKE DURING A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22963834 ↗MalfunctionJul 10, 2025Break; Break
IT WAS REPORTED THAT THE INSERTER BROKE DURING INSERTION OF AN IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22469425 ↗MalfunctionJun 7, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE INSERTER BROKE DURING A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22162153 ↗MalfunctionApr 30, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT AN INSERTER BROKE DURING A SPINAL SURGICAL PROCEDURE. AFTER THE IMPLANT WAS PLACED IN THE DISC SPACE, THE INSERTER WAS REMOVED. UPON REMOVAL, IT WAS OBSERVED THAT THE PORTION OF THE TIP THAT LOCKS INTO THE IMPLANT HAD FRACTURED. THE BROKEN TIP WAS RETRIEVED WITHOUT COMPLICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21938301 ↗MalfunctionMar 6, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE INSERTER BROKE WHILE BEING REMOVED FROM AN INTERBODY SPACER DURING A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21542404 ↗MalfunctionFeb 26, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE INSERTER LOCKING MECHANISM SNAPPED, AND THE INSERTER WILL NO LONGER GRAB CAGES PROPERLY. THERE WAS NO REPORT OF PATIENT HARM DUE TO THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21472448 ↗MalfunctionDec 6, 2024Material Separation; Material Separation
IT WAS REPORTED THAT THE INSERTER WAS NOT WORKING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20865245 ↗InjuryNov 15, 2024Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE INSERTER BROKE OFF WHEN TRYING TO ADJUST A CAGE. THE TIP REMAINS IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 20695975 ↗MalfunctionNov 1, 2024Break; Break
IT WAS REPORTED THAT THE INSERTER IS BROKEN.
Patient problems: Insufficient Information
MAUDE report 20588224 ↗MalfunctionNov 1, 2024Break; Break
IT WAS REPORTED THAT THE INSERTER IS BROKEN.
Patient problems: Insufficient Information
MAUDE report 20588206 ↗MalfunctionOct 21, 2024Break; Break
IT WAS REPORTED THAT THE INSERTER WAS RECEIVED BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20497714 ↗MalfunctionOct 17, 2024Break; Break
IT WAS REPORTED THAT THE INSERTER IS BROKEN.
Patient problems: Insufficient Information
MAUDE report 20472691 ↗MalfunctionAug 27, 2024Material Separation; Material Separation
IT WAS REPORTED THAT THE DISTAL PRONG BROKE OFF DURING A CASE. ALL PIECES WERE RETRIEVED FROM THE PATIENT BUT DISCARDED AT THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20080950 ↗MalfunctionAug 22, 2024Material Separation; Material Separation
IT WAS REPORTED THAT THE INSERTER WAS FOUND BROKEN IN A SET. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20035565 ↗MalfunctionJun 14, 2024Material Separation; Material Separation
IT WAS REPORTED THAT THE INSERTER WAS RECEIVED WITH THE DISTAL PRONG MISSING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19539054 ↗MalfunctionMay 21, 2024Material Separation; Material Separation
IT WAS REPORTED THAT THE DISTAL PRONG BROKE OFF DURING A CASE. THE PIECE WAS RETRIEVED FROM THE PATIENT. THERE WAS NO REPORT OF PATIENT SYMPTOMS DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19359747 ↗MalfunctionApr 29, 2024Material Separation; Material Separation
IT WAS REPORTED THAT THE INSERTER WILL NOT CONNECT TO THE CAGE. THERE IS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19209912 ↗MalfunctionApr 3, 2024Fracture; Fracture
IT WAS REPORTED THE TIP THAT ATTACHES TO THE IMPLANT BROKE OFF ON THE BACK TABLE OF THE OPERATING ROOM. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19034445 ↗MalfunctionMar 18, 2024Material Separation; Material Separation
THE ARM OF THE INSERTER IS BROKEN OFF. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18926888 ↗MalfunctionDec 14, 2023Material Separation; Material Separation
IT WAS REPORTED THE TIP OF THE INSERTER BROKE OFF WHILE INSERTING THE CAGE. THE TIP WAS RETRIEVED AND DISCARDED AT THE HOSPITAL. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18326958 ↗MalfunctionNov 29, 2023Material Separation; Material Separation
IT WAS REPORTED THE ANTEROLATERAL INSERTER WAS NOT WORKING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18232899 ↗MalfunctionNov 17, 2023Material Separation; Material Separation
A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE ON AN UNKNOWN DATE. AFTER THE SURGEON IMPLANTED THE SPACER INTO THE PATIENT, IT WAS NOTED THE DISTAL TIP OF THE INSERTER BROKE OFF. ALL PIECES WERE RETRIEVED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18161062 ↗
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
- IdentiTi 232-10-85-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall2 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 03.30.300Medacta 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
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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