Invictus 15610Recalls & reported problems
Alphatec Spine, Inc. · Modular Polyaxial Reduction Tulip · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190376239316), received between Aug 8, 2022 and Apr 2, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
Patient problems
- Fall1
- Inadequate Pain Relief1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
AROUND 3-MONTHS AFTER UNDERGOING POSTERIOR FIXATION SPINAL SURGERY, A PATIENT REPORTED LOW BACK PAIN AFTER SUSTAINING A FALL. A RADIOGRAPH IMAGE REVEALED A TULIP DISENGAGED FROM THE SCREW SHANK. REVISION SURGERY WAS PERFORMED.
Patient problems: Fall; Pain
MAUDE report 19028469 ↗InjuryAug 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
DURING A REVISION SURGERY, THE SURGEON NOTED A TULIP HEAD DISASSOCIATED FROM THE RIGHT S1 SCREW SHANK. THE HARDWARE WAS REMOVED FROM THE PATIENT.
Patient problems: Inadequate Pain Relief
MAUDE report 15188500 ↗
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- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.