STERILE TRAC SYSTEM SP-ST-6704Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841036177959), received between Jan 13, 2020 and Jan 13, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Dull, Blunt” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2020Fracture; Fracture

  IT WAS REPORTED THE SCREW TIP FRACTURED DURING USE AND RESULTED IN A RETAINED FOREIGN BODY IN THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9582398 ↗
• MalfunctionJan 13, 2020Dull, Blunt; Dull, Blunt

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9581118 ↗

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