STERILE TRAC SYSTEM 12 PACK SP-ST-6704-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841036198565), received between Nov 5, 2020 and Nov 5, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2020Fracture; Fracture

  IT WAS REPORTED THE SCREW FRACTURED UPON IMPLANTATION RESULTING IN A RETAINED FOREIGN BODY. THE SCREW HEAD WAS RECOVERED BUT THE SCREW BODY WAS LEFT IN THE PATIENT'S BODY AT THE SURGEON'S DISCRETION. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SCREW. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10791415 ↗

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