Invictus 15100Recalls & reported problems
Alphatec Spine, Inc. · Set Screw · Class 2 · Implant
Quick summary
This Alphatec Spine Invictus set screw is part of a thoracolumbosacral pedicle screw system used to hold spinal hardware in place during back surgery. Most of the 65 reports describe the small screw backing out or loosening after surgery, sometimes requiring a second operation to remove or replace the implants, and a few mention broken or slipping parts. 34 reports involved injuries and no deaths were reported. No recalls name this device.
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
- 65
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00190376137902), received between Apr 18, 2019 and Aug 11, 2026 — classified as 34 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (39 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 Dislocated39
- Detachment of Device or Device Component18
- Device Slipped3
- Entrapment of Device2
- Fracture2
- Break1
- Device-Device Incompatibility1
- Loose or Intermittent Connection1
Patient problems
- Failure of Implant33
- No Clinical Signs, Symptoms or Conditions22
- No Known Impact Or Consequence To Patient9
- Insufficient Information6
- Pain2
- Device Embedded In Tissue or Plaque1
- Fall1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2026Device Dislodged or Dislocated
It was reported that the set screw came loose postoperatively. Revision surgery occurred to remove the screw.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 50214081 ↗InjuryApr 2, 2026Device Dislodged or Dislocated
A PATIENT UNDERWENT A SPINAL SURGERY FROM L4-S1. ABOUT 2 YEARS POSTOPERATIVELY, RADIOGRAPHIC IMAGING REVEALED A SET SCREW HAD BACKED OUT AT THE L4 LEVEL. AN ALIF AND PTP REVISION SURGERY OCCURRED ON (B)(6) 2026 TO REPLACE THE HARDWARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766738 ↗InjuryApr 2, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE SET SCREW HAD BACKED OUT ABOUT 6 MONTHS POSTOPERATIVELY. REVISION SURGERY IS PLANNED FOR (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766683 ↗MalfunctionApr 2, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE SET SCREW HAD BACKED OUT ABOUT 6 WEEKS POSTOPERATIVELY. THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766567 ↗MalfunctionFeb 24, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE SET SCREWS HAD BACKED OUT POSTOPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24431525 ↗InjuryFeb 18, 2026Device Dislodged or Dislocated
A PATIENT UNDERWENT A SPINAL SURGERY ON (B)(6) 2025. POSTOPERATIVELY, IT WAS REPORTED THAT A SET SCREW HAD BACKED OUT. REVISION SURGERY OCCURRED ON (B)(6) 2026 TO REMOVE THE CONSTRUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24378060 ↗MalfunctionJul 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
AROUND 6 WEEKS POSTOPERATIVELY, RADIOGRAPHIC IMAGES REVEALED TWO SET SCREWS HAD BACKED OUT. THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY. THIS IS REPORT 2 OF 2.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 22565363 ↗MalfunctionJul 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
AROUND 6 WEEKS POSTOPERATIVELY, RADIOGRAPHIC IMAGES REVEALED TWO SET SCREWS HAD BACKED OUT. THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY. THIS IS REPORT 1 OF 2.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 22565180 ↗MalfunctionJul 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT UNDERWENT A SPINAL SURGERY ON AN UNKNOWN DATE. ABOUT 6 WEEKS POSTOPERATIVELY RADIOGRAPHIC IMAGES REVEALED THAT TWO SET SCREWS HAD BECOME DISENGAGED, AND THE ROD SLIPPED. THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY. THIS IS REPORT 2 OF 2.
Patient problems: Failure of Implant
MAUDE report 22524396 ↗MalfunctionJul 16, 2025Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement
A PATIENT UNDERWENT A SPINAL SURGERY ON AN UNKNOWN DATE. ABOUT 6 WEEKS POSTOPERATIVELY RADIOGRAPHIC IMAGES REVEALED THAT TWO SET SCREWS HAD BECOME DISENGAGED, AND THE ROD SLIPPED. THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY. THIS IS REPORT 1 OF 2.
Patient problems: Failure of Implant
MAUDE report 22524278 ↗InjuryJun 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT UNDERWENT A L2-S1 POSTERIOR LUMBAR FUSION ON (B)(6) 2024. AT THE 6-MONTH POSTOPERATIVE VIST, RADIOGRAPH IMAGES REVEALED THAT BOTH L2 SET SCREWS HAD BACKED OUT FROM THE PEDICLE SCREW. REVISION SURGERY WAS PERFORMED TO REMOVE BOTH SET SCREWS AND REPLACE WITH NEW ONES. THIS IS REPORT 1 OF 2.
Patient problems: Failure of Implant
MAUDE report 22310886 ↗InjuryJun 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT UNDERWENT A SPINAL SURGERY ON AN UNKNOWN DATE. AROUND 6 MONTHS POSTOPERATIVELY, A RADIOGRAPH IMAGE REVEALED THAT A SET SCREW HAD BACKED OUT. REVISION SURGERY OCCURRED TO REMOVE THE SET SCREW. AROUND 6 WEEKS POSTOPERATIVELY OF THE REVISION SURGERY, A "RADIOGRAPH" IMAGE REVEALED THAT ANOTHER SET SCREW HAD BACKED OUT. THERE ARE NO PLANS FOR REVISION SURGERY FOR THIS SECOND INCIDENT. THIS IS REPORT 1 OF 2.
Patient problems: Failure of Implant
MAUDE report 22310815 ↗MalfunctionJun 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT UNDERWENT A SPINAL SURGERY ON AN UNKNOWN DATE. AROUND 6 MONTHS POSTOPERATIVELY, A RADIOGRAPH IMAGE REVEALED THAT A SET SCREW HAD BACKED OUT. REVISION SURGERY OCCURRED TO REMOVE THE SET SCREW. AROUND 6 WEEKS POSTOPERATIVELY OF THE REVISION SURGERY, A RADGIOGRAPH IMAGE REVEALED THAT ANOTHER SET SCREW HAD BACKED OUT. THERE ARE NO PLANS FOR REVISION SURGERY FOR THIS SECOND INCIDENT. THIS IS REPORT 2 OF 2.
Patient problems: Failure of Implant
MAUDE report 22310808 ↗InjuryJun 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT UNDERWENT A L2-S1 POSTERIOR LUMBAR FUSION ON (B)(6) 2024. AT THE 6-MONTH POSTOPERATIVE VIST, RADIOGRAPH IMAGES REVEALED THAT BOTH L2 SET SCREWS HAD BACKED OUT FROM THE PEDICLE SCREW. REVISION SURGERY WAS PERFORMED TO REMOVE BOTH SET SCREWS AND REPLACE WITH NEW ONES. THIS IS REPORT 2 OF 2.
Patient problems: Failure of Implant
MAUDE report 22310612 ↗InjuryJun 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT UNDERWENT A SPINAL SURGERY ON AN UNKNOWN DATE. POSTOPERATIVELY, IT WAS REPORTED THAT FOUR SET SCREWS HAD BACKED OUT. REVISION SURGERY WAS PERFORMED TO REMOVE THE SCREWS AND ASSOCIATED RODS. THIS IS REPORT 4 OF 4.
Patient problems: Failure of Implant
MAUDE report 22287556 ↗InjuryJun 18, 2025Fracture; Fracture
A PATIENT UNDERWENT A SPINAL SURGERY ON AN UNKNOWN DATE. POSTOPERATIVELY, IT WAS REPORTED THAT FOUR SET SCREWS HAD BACKED OUT. REVISION SURGERY WAS PERFORMED TO REMOVE THE SCREWS AND ASSOCIATED RODS. THIS IS REPORT 3 OF 4.
Patient problems: Failure of Implant
MAUDE report 22287480 ↗InjuryJun 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT UNDERWENT A SPINAL SURGERY ON AN UNKNOWN DATE. POSTOPERATIVELY, IT WAS REPORTED THAT FOUR SET SCREWS HAD BACKED OUT. REVISION SURGERY WAS PERFORMED TO REMOVE THE SCREWS AND ASSOCIATED RODS. THIS IS REPORT 2 OF 4.
Patient problems: Failure of Implant
MAUDE report 22287459 ↗InjuryJun 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT UNDERWENT A SPINAL SURGERY ON AN UNKNOWN DATE. POSTOPERATIVELY, IT WAS REPORTED THAT FOUR SET SCREWS HAD BACKED OUT. REVISION SURGERY WAS PERFORMED TO REMOVE THE SCREWS AND ASSOCIATED RODS. THIS IS REPORT 1 OF 4.
Patient problems: Failure of Implant
MAUDE report 22287425 ↗MalfunctionJun 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
AROUND 6 MONTHS POSTOPERATIVELY, A RADIOGRAPH IMAGE REVEALED TWO SET SCREWS BACKING OUT OF THE CONSTRUCT. THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY. THIS IS REPORT 2 OF 2.
Patient problems: Failure of Implant
MAUDE report 22169026 ↗MalfunctionJun 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
AROUND 6 MONTHS POSTOPERATIVELY, A RADIOGRAPH IMAGE REVEALED TWO SET SCREWS BACKING OUT OF THE CONSTRUCT. THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY. THIS IS REPORT 1 OF 2.
Patient problems: Failure of Implant
MAUDE report 22169013 ↗MalfunctionMay 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2024. AT THE 1-YEAR POSTOPERATIVE VISIT, RADIOGRAPH IMAGES REVEALED A SET SCREW BACKOUT AND ROD SLIPPAGE.
Patient problems: Failure of Implant
MAUDE report 22065791 ↗MalfunctionMar 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT FELL ABOUT 1 YEAR POSTOPERATIVELY. RADIOGRAPH IMAGES REVEALED A SET SCREW HAD BACKED OUT. THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 21531715 ↗InjuryFeb 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AROUND ONE YEAR AFTER THE INITIAL SURGERY, THE PATIENT UNDERWENT REVISION SURGERY TO EXTEND THE EXISTING CONSTRUCT. DURING THE PROCEDURE, IT WAS OBSERVED THAT ONE OF THE PREVIOUSLY IMPLANTED SET SCREWS HAD BACKED OUT, WHILE ANOTHER WAS FOUND TO BE LOOSE. BOTH SET SCREWS WERE REMOVED AND REPLACED. THIS IS REPORT 2 OF 2.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 21381235 ↗InjuryFeb 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AROUND ONE YEAR AFTER THE INITIAL SURGERY, THE PATIENT UNDERWENT REVISION SURGERY TO EXTEND THE EXISTING CONSTRUCT. DURING THE PROCEDURE, IT WAS OBSERVED THAT ONE OF THE PREVIOUSLY IMPLANTED SET SCREWS HAD BACKED OUT, WHILE ANOTHER WAS FOUND TO BE LOOSE. BOTH SET SCREWS WERE REMOVED AND REPLACED. THIS IS REPORT 1 OF 2.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 21381157 ↗MalfunctionDec 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A SET SCREW BACKED OUT POSTOPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 20870851 ↗
Other Thoracolumbosacral pedicle screw system devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.