ACUMED 30-0345-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10806378018312), received between Oct 15, 2025 and Oct 15, 2025 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K122538); 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.

• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT THE SCREW HEAD SHEARED OFF WHEN IMPLANTING IN THE PLATE WITH A T8 SCREWDRIVER. THE SCREW WAS LEFT IN SITU AND THE HEAD WAS DISPOSED OF.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23287511 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122538. One submission often covers many models, so check the product and lot details in each record.

• Z-1199-2017 · Jan 19, 2017 · Terminated
  6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fr