PedFuse® 01-80101Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190361010586), received between May 17, 2019 and May 23, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K092420); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2019Mechanical Problem; Mechanical Problem

  ON (B)(6) 2018, IT WAS REPORTED THAT THE PEDFUSE RESET LOCKING CAPS SHED A STRIP OF METAL WHILE TIGHTENING DURING SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8638695 ↗
• MalfunctionMay 17, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SPINEFRONTIER SALES REPRESENTATIVE REPORTED THAT THE SURGEON ENCOUNTERED DIFFICULTY ADVANCING THE SET SCREW INTO THE TULIP DURING INITIAL PLACEMENT. THE SET SCREW GOT CROSS THREADED DURING THE PROCESS AND HAD TO BE REPLACED. THIS WAS THE SECOND SET SCREW CROSS THREADING OCCURRENCE DURING THIS CASE. THE FIRST OCCURRENCE WAS REPORTED UNDER MDR 3005977257-2019-00004.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8622112 ↗
• MalfunctionMay 17, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SPINEFRONTIER SALES REPRESENTATIVE REPORTED THAT THE SURGEON ENCOUNTERED DIFICULTY ADVANCING THE SET SCREW INTO THE TULIP DURING INITIAL PLACEMENT. THE SET SCREW GOT CROSS THREADED DURING THE PROCESS AND HAD TO BE REPLACED. THIS WAS THE FIRST OF TWO SET SCREW CROSS THREADING OCCURRENCE DURING THIS CASE. THE SECOND OCCURRENCE WAS REPORTED UNDER MDR 3005977257-2019-00005.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8622107 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092420. One submission often covers many models, so check the product and lot details in each record.

• Z-1926-2013 · Mar 14, 2013 · Terminated
  Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature th
• Z-1737-2013 · Dec 30, 2011 · Terminated
  KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicl