PedFuse 01-80325Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190361028185), received between Oct 2, 2023 and Oct 2, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K123164); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2023Break; Break

  THE EVENT TOOK PLACE DURING A 2 LEVEL PEDICLE SCREW CONSTRUCT L3-L5 USING MIDLINE TECHNIQUE. TWO SET SCREW THREADS SHEARED DURING FINAL TORQUE STEP ON THE SAME PEDICLE SCREW. L5 SCREW WAS WHERE THE ISSUE OCCURED. ALL SET SCREWS WERE PLACED; THE ORDER OF FINAL TIGHTENTING IS UNKNOWN. THE FIRST FAILED SET SCREW WAS REMOVED AND REPLACED WITH A SECOND SET SCREW. AFTER THE SECOND SET SCREW FAILED, BOTH THE PEDICLE SCREW AND SET SCREW WERE REMOVED AND REPLACED. THE ROD REDUCER WAS USED PRIOR TO FINAL TIGHTENING THE THIRD SET SCREW. THE THIRD SET SCREW AND SECOND PEDICLE SCREW WERE SUCCESSFUL. SHEARED MATERIAL FROM THE SET SCREWS WERE REMOVED WITH FORCEPS AND IRRIGATED WITH ANTIBIOTICS. NO PATIENT HARM AND THE SURGERY WAS COMPLETED AS INTENDED. SET SCREW, PEDICLE SCREW AND TORQUE HANDLE WERE RETURNED FOR EVALUATION. 01-80325, (B)(6) SET SCREW (QTY 2). 01-80169-45R, IE18 PEDICLE SCREW. 11-80032, EH21 9.5N-M TORQUE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852446 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123164. One submission often covers many models, so check the product and lot details in each record.

• Z-1479-2015 · Mar 5, 2015 · Terminated
  SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of
• Z-0555-2014 · Nov 20, 2013 · Terminated
  PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset a
• Z-0554-2014 · Nov 20, 2013 · Terminated
  PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset
• Z-0553-2014 · Nov 20, 2013 · Terminated
  PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset a
• Z-0544-2014 · Oct 18, 2013 · Terminated
  PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adju
• Z-0624-2014 · Sep 11, 2013 · Terminated
  PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.