STERILE TRAC SYSTEM 15-6104Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841036147686), received between Dec 5, 2019 and Mar 31, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K972322); 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.

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.

• InjuryMar 31, 2022Fracture; Fracture

  IT WAS REPORTED THE SCREW HEAD FRACTURED WHEN THE SURGEON ATTEMPTED FINAL TIGHTENING AND THE BODY OF THE SCREW REMAINS IN THE PATIENT'S BONE. THE SURGEON PLACED THE PLATE OVER THE SCREW AND USED ANOTHER HOLE TO FIXATE THE PLATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13967841 ↗
• MalfunctionDec 5, 2019Fracture; Fracture

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9420696 ↗
• InjuryDec 5, 2019Fracture; Fracture

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 9420688 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K972322. One submission often covers many models, so check the product and lot details in each record.

• Z-0629-2021 · Nov 25, 2020 · Terminated
  Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone