APTUS A-5750.18/1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630008405427), received between Oct 10, 2025 and Oct 10, 2025 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K051567); 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 10, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ONE 18 MM SCREW BROKE OFF INTO THE LEFT RADIUS DURING SURGICAL PROCEDURE. HEAD OF SCREW RETRIEVED AND PLACED ON STERILE FIELD; HOWEVER, THE SURGEON DETERMINED THAT IT WOULD CAUSE MORE DAMAGE TO TRY TO DRILL OUT THE REST OF THE SCREW SHAFT AND IT WAS LEFT IN THE RADIUS. NO HARM TO PATIENT. THE HEAD OF THE SCREW WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23266831 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051567. One submission often covers many models, so check the product and lot details in each record.

• Z-1549-2026 · Jan 9, 2026 · Open, Classified
  Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation syste