IdentiTiRecalls & reported problems across all models
Alphatec Spine, Inc. · 31 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one IdentiTi model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 68
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls
- 1
We found 31 models of IdentiTi by Alphatec Spine, Inc. in the FDA's device registry (GUDID). Together they are named in 68 adverse event reports in the FDA's MAUDE database, received between Aug 20, 2020 and Sep 8, 2026 — classified as 15 injuries, 53 malfunctions.
The most frequently reported specific device problem is “Break” (34 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
IdentiTi recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 26, 2024Open, Classified
Due to reports of intraoperative graft bolt implantation breakages.
Z-1182-2024 · Root cause: Device Design · names 12 of these models · Recall details · FDA record ↗
Most reported IdentiTi problems
Device problems
- Break34
- Material Separation27
- Fracture12
- Device Damaged by Another Device6
- Device Dislodged or Dislocated3
- Damaged Thread1
- Material Twisted/Bent1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions45
- Failure of Implant20
- Insufficient Information5
- Foreign Body In Patient4
- Device Embedded In Tissue or Plaque1
- Dysphagia/ Odynophagia1
- No Known Impact Or Consequence To Patient1
- Pain1
IdentiTi models
31 models, most reported first. Each model has its own page with its reports, recalls and device details.
- IdentiTi 232-10-85-300Intervertebral fusion device with integrated fixation, lumbar1 recall8 reports
- IdentiTi 232-10-85-250Intervertebral fusion device with integrated fixation, lumbar1 recall5 reports
- IdentiTi 132-10-85-300Intervertebral fusion device with integrated fixation, lumbar1 recall3 reports
- IdentiTi 232-10-85-350Intervertebral fusion device with integrated fixation, lumbar1 recall2 reports
- IdentiTi 232-11-90-350Intervertebral fusion device with integrated fixation, lumbar1 recall1 report
- IdentiTi 132-10-85-250Intervertebral fusion device with integrated fixation, lumbar1 recall0 reports
- IdentiTi 132-10-85-350Intervertebral fusion device with integrated fixation, lumbar1 recall0 reports
- IdentiTi 132-10-90-250Intervertebral fusion device with integrated fixation, lumbar1 recall0 reports
- IdentiTi 132-10-90-300Intervertebral fusion device with integrated fixation, lumbar1 recall0 reports
- IdentiTi 132-10-90-350Intervertebral fusion device with integrated fixation, lumbar1 recall0 reports
- IdentiTi 232-11-90-250Intervertebral fusion device with integrated fixation, lumbar1 recall0 reports
- IdentiTi 232-11-90-300Intervertebral fusion device with integrated fixation, lumbar1 recall0 reports
- IdentiTi 233-150Intervertebral fusion device with integrated fixation, lumbar29 reports
- IdentiTi 134-07161407-SIntervertebral fusion device with integrated fixation, cervical3 reports
- IDENTITI 100-06185510-SIntervertebral fusion device with bone graft, thoracic1 report
- IdentiTi 120-08093010-SIntervertebral fusion device with bone graft, lumbar1 report
- IdentiTi 121-100-50Intervertebral fusion device with bone graft, thoracic1 report
- IDENTITI 100-06225015-SIntervertebral fusion device with bone graft, thoracic1 report
- IDENTITI 100-08186010-SIntervertebral fusion device with bone graft, thoracic1 report
- IdentiTi 134-1-35-14Intervertebral fusion device with integrated fixation, cervical1 report
- IdentiTi 168-30ELEVATOR1 report
- IdentiTi 134-3-35-16Intervertebral fusion device with integrated fixation, cervical1 report
- IdentiTi 134-05141207-SIntervertebral fusion device with integrated fixation, cervical1 report
- IdentiTi 134-07141207-SIntervertebral fusion device with integrated fixation, cervical1 report
- IdentiTi 134-07161410-SIntervertebral fusion device with integrated fixation, cervical1 report
- IdentiTi 134-07181607-SIntervertebral fusion device with integrated fixation, cervical1 report
- IdentiTi 134-08181607-SIntervertebral fusion device with integrated fixation, cervical1 report
- IdentiTi 132-20-50-250Intervertebral fusion device with integrated fixation, lumbar1 report
- IdentiTi 132-20-60-250Intervertebral fusion device with integrated fixation, lumbar1 report
- IdentiTi 232-13-85-300Intervertebral fusion device with integrated fixation, lumbar1 report
- IdentiTi 232-13-90-300Intervertebral fusion device with integrated fixation, lumbar1 report
Recent IdentiTi adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJun 2, 2026Device Damaged by Another Device
A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE ON (B)(6) 2026. IT WAS REPORTED THAT DURING THE PROCEDURE THE SCREW ADVANCED THROUGH THE SPACER BYPASSING THE LOCKING MECHANISM. THE SCREW AND SPACER REMAIN IN SITU.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25364576 ↗MalfunctionMay 27, 2026Device Damaged by Another Device
A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE ON (B)(6) 2026. IT WAS REPORTED THAT DURING THE PROCEDURE THE SCREW ADVANCED THROUGH THE SPACER, BYPASSING THE LOCKING MECHANISM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25306925 ↗MalfunctionMay 5, 2026Device Damaged by Another Device
A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE ON (B)(6) 2026. IT WAS REPORTED THAT DURING THE CASE, THE GRAFT BOLT ADVANCED ALL THE WAY THROUGH THE INTERBODY SPACER. THE SPACER AND BOLT WERE REMOVED, AND THE SPACER WAS SUCCESSFULLY RE-IMPLANTED WITH A NEW BOLT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25085617 ↗MalfunctionApr 9, 2026Break
DURING INSERTION INTO THE INFERIOR C3/C4 VERTEBRAE, THE SCREW HEAD FRACTURED. THE DETACHED SCREW HEAD WAS RETRIEVED. THE REMAINING PORTION OF THE SCREW SHANK WAS LEFT IN SITU WITHIN THE INTERBODY SPACER ALONGSIDE THE INTACT SCREW. THE SPACER WAS LOCKED, AND THE PROCEDURE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24831488 ↗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 ↗MalfunctionDec 30, 2025Fracture; Fracture
IT WAS REPORTED THAT THE SPACER ALMOST SHEARED OFF OF THE INSERTER DURING A SPINAL PROCEDURE. A SECOND SPACER WAS USED SUCCESSFULLY.
Patient problems: Failure of Implant
MAUDE report 23928901 ↗MalfunctionNov 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT UNDERWENT A 1-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE ON (B)(6) 2025. ABOUT 6 MONTHS POSTOPERATIVELY, A RADIOGRAPHIC IMAGE REVEALED THAT THE LOCKING MECHANISM HAD FAILED CAUSING THE SCREW TO BACKOUT.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 23561676 ↗MalfunctionNov 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT UNDERWENT A 2-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE ON (B)(6) 2025. AROUND 6 MONTHS POSTOPERATIVELY, A RADIOGRAPHIC IMAGE REVEALED THAT THE LOCKING MECHANISM HAD FAILED CAUSING THE SCREW TO BACKOUT. THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 23545302 ↗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 ↗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 ↗MalfunctionJul 24, 2025Break; Break
A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) ON (B)(6) 2025. THE GRAFT BOLT BROKE UPON INSERTION INTO THE STANDALONE CAGE. HALF OF THE BOLT REMAINS STUCK IN THE THREADS OF THE ALIF CAGE AND ENDPLATE OF THE VERTEBRAL BODY.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 22587193 ↗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 ↗MalfunctionJul 1, 2025Break; Break
A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) AT THE L4-L5 LEVEL. DURING THE PROCEDURE, NO HOLE PREPARATION WAS PERFORMED PRIOR TO SCREW INSERTION. WHILE INSERTING THE FIRST GRAFT BOLT INTO THE INTERBODY SPACER, THE INSERTION ANGLE WAS TOO SHALLOW, RESULTING IN BOLT BREAKAGE. THE BROKEN BOLT WAS REMOVED, AND THE SPACER WAS REPOSITIONED. A SECOND ATTEMPT TO PLACE A GRAFT BOLT ALSO RESULTED IN BREAKAGE; HOWEVER, THE FRACTURED BOLT MAINTAINED ADEQUATE BONY PURCHASE AND WAS LEFT IN PLACE, ALONG WITH THE LATERAL SCREWS. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS, AND THE PATIENT IS CURRENTLY DOING WELL POSTOPERATIVELY. THIS IS REPORT 2 OF 2.
Patient problems: Failure of Implant
MAUDE report 22377671 ↗
Other Alphatec Spine, Inc. products
- Invictus96 models · 448 reports
- ATEC Lateral Navigation Disc Prep Instruments2 models · 0 reports · 2 recalls
- Calibrate44 models · 40 reports · 1 recall
- Arsenal18 models · 86 reports
- Illico20 models · 69 reports
- AMP5 models · 4 reports · 1 recall
- Insignia34 models · 54 reports
- Trestle Luxe24 models · 38 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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