Indus® IM71059-03Recalls & reported problems
Spinefrontier, Inc. · Invue, Self Drilling Screw, Tapered, 4.2 x 16mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190361002130), received between Jun 19, 2018 and Sep 14, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
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.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Off-Label Use1
- Use of Device Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2019Off-Label Use; Off-Label Use
SPINEFRONTIER SALES REPRESENTATIVE REPORTED THAT DURING EXTREME, 4 LEVEL LORDOSIS CASE, THE SURGEON HAD TO BEND THE INVUE PLATE TO CONFORM TO THE EXTREME (C5 - C7) LORDOSIS. THE ANGULATION OF THE SCREW WAS GREATER THAN THE RECOMMENDED 14° VARIABLE SCREW ANGULATION OUTLINED IN THE SURGICAL TECHNIQUE. THE EXTREME ANGULATION LED TO A THIN FLEXIBLE STRIP OF THE SCREW THREADS WAS RUBBED OFF BY THE PLATE. THE SURGEON REMOVED THE THIN PIECE OF METAL FROM THE SURGICAL SITE AND COMPLETED THE CASE WITHOUT ANY COMPLICATIONS OR PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9056585 ↗MalfunctionJun 19, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method
SPINEFRONTIER RECEIVED INFORMATION FORM A CLINICIAN STATING THAT METAL STRIPS SHEARED OFF THE THREADS OF THE LEFT C7 SCREW DUE TO THE SEVERE ANGLE BETWEEN THE PLATE AND THE SCREW. THE SHARED SCREW WAS REMOVED AND REPLACED WITH A NEW ONE, IT WAS REPORTED THAT THE NEW SCREW SHEARED IN THE SAME MANNER AS THE FIRST, THE SECOND SCREW WAS LEFT IN-PLACE. THIS INCIDENT OCCURRED DURING A C6 -C7 POSTERIOR DECOMPRESSION AND FUSION CASE ON (B)(6) MALE PATIENT FOLLOWING A SEVERE MVA.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7616847 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
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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