IB3D™ PL Spinal System A24000000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03613720286677), received between Nov 24, 2025 and Jan 16, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K241164); they may or may not involve this specific model.

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 18, 2026.

Recalls naming this device

1. Oct 29, 2025Class IIOpen, Classified

   Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.

   Z-1038-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, THE INSERTERS WERE TWISTING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24091143 ↗
• MalfunctionJan 16, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT, THE INSERTERS WERE TWISTING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24091128 ↗
• MalfunctionNov 24, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR TRANSFORAMINAL LUMBAR INTE RBODY FUSION. IT WAS REPORTED THAT THE INSTRUMENT HANDLES WERE TWISTING DURING ROUTINE CHECKING IN THE STERILE PROCESSING DEPARTMENT, AND THE INSTRUMENT BROKE. THERE WAS NO PATIENT INVOLVED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629499 ↗
• MalfunctionNov 24, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3-4 TRANSFORAM INAL LUMBAR INTERBODY FUSION (TLIF) FOR AN INDICATION OF SPINAL STENOSIS. IT WAS REPORTED THAT AFTER THE INTERBODY CAGE WAS PLACED IN ITS FINAL POSITION, THE SURGEON ATTEMPTED TO ROTATE THE CAGE/INTERBODY, BUT THE RED PART OF THE HANDLE ROTATED INSTEAD OF THE CAGE/INTERBODY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629498 ↗
• MalfunctionNov 24, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE RED HANDLE OF THE INSERTER ROTATED INSTEAD OF THE CAGE. THE SURGEON HAD SELECTED THE SIZE CAGE TO BE USED, AND UPON ATTEMPTING TO ROTATE IT, ONLY THE HANDLE MOVED WHILE THE CAGE REMAINED STATIONARY. THE CAGE WAS SUCCESSFULLY EXTRACTED, AND AN ALTERNATE ROTATING CAGE FROM ANOTHER MANUFACTURER WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629494 ↗
• MalfunctionNov 24, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT THE INSTRUMENT HANDLES WERE TWISTING DURING ROUTINE CHECKING IN THE STERILE PROCESSING DEPARTMENT, AND THE INSTRUMENT BROKE. THERE WAS NO PATIENT INVOLVED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629447 ↗
• MalfunctionNov 24, 2025Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR INTERBODY FUSION (PLIF) L3-4 FOR AN INDICATION OF DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT THE INSERTER HANDLE PHYSICALLY TWISTED WHILE ATTEMPTING TO ROTATE THE CAGE AND DID NOT ALLOW THE CAGE TO FULLY ROTATE, TWISTING 45 DEGREES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629420 ↗
• MalfunctionNov 24, 2025Break; Mechanical Problem; Break; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3-S2 SPINAL FUSION PROCEDURE WITH INTERBODIES AT L3-S1. IT WAS REPORTED THAT THE INSERTER COULD NOT HANDLE THE REQUIRED TORQUE AND BROKE. PLIERS WERE USED ON THE TIGHTENING MECHANISM TO COMPLETE THE IMPLANT ROTATION WITHOUT THE HANDLE LOOSENING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629417 ↗
• MalfunctionNov 24, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR TLIF PROCEDURE. IT WAS REPORTED THAT THE HANDLE OF THE INSTRUMENTS WAS BENT AND STRIPPED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629415 ↗
• MalfunctionNov 24, 2025Break; Mechanical Problem; Break; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3-S2 SPINAL FUSION PROCEDURE WITH INTERBODIES AT L3-S1. IT WAS REPORTED THAT THE INSERTER COULD NOT HANDLE THE REQUIRED TORQUE AND BROKE. PLIERS WERE USED ON THE TIGHTENING MECHANISM TO COMPLETE THE IMPLANT ROTATION WITHOUT THE HANDLE LOOSENING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629403 ↗
• MalfunctionNov 24, 2025Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR LUMBAR INTERBODY FUSION (PLIF) L3-4 FOR AN INDICATION OF DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT THE INSERTER HANDLE PHYSICALLY TWISTED WHILE ATTEMPTING TO ROTATE THE CAGE AND DID NOT ALLOW THE CAGE TO FULLY ROTATE, TWISTING 45 DEGREES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629399 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241164. One submission often covers many models, so check the product and lot details in each record.

• Z-1039-2026 · Oct 29, 2025 · Open, Classified
  Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174