Modular Fixation System 165-001Recalls & reported problems
Life Spine, Inc. · Modular Tulip Head, 4.0mm-7.5mm · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190837076436), received between Jun 23, 2022 and Aug 12, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
- Migration1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Musculoskeletal problem1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
DURING A REVISION IS WAS NOTED THAT QTY 2 MODULAR HEADS DISASSEMBLED INSITU.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19964984 ↗MalfunctionSep 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
InjuryJun 23, 2022Migration; Migration
IT WAS REPORTED THAT TWO CENTERLINE MODULAR HEADS CAME OFF OF THE SCREWS DURING SURGERY.
Patient problems: Unspecified Musculoskeletal problem
MAUDE report 14788981 ↗
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.