NA 02.211.413SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982055057), received between Apr 19, 2022 and Apr 19, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionApr 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE DEPTH GAUGE DEVICES WERE BENT, DISCOLORED AND STICKING; AND THE FIXATION PLATE DEVICE DID NOT ATTACH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 2.7 VAL ANTLAT CALC PL LG 56 LT-S DEVICE. THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14144469 ↗