MAXFRAME 03.312.820Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982260987), received between May 10, 2019 and May 10, 2019 — classified as 1 malfunction.

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

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.

• MalfunctionMay 10, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE TEAM WAS DOING AN UNKNOWN SURGERY USING A MAXFRAME. ON TWO DIFFERENT OCCASIONS DURING THE PROCEDURE, THE BAND ID AND STRUT ID PLASTIC LABEL BROKE. ANOTHER STRUT AND BAND ID AND PLUG WERE USED TO COMPLETE THE SURGERY WITHOUT SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A MAXFRAME(TM) STRUT ID BAND SET. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8601116 ↗