NA 288228Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705027057), received between Oct 22, 2019 and Oct 22, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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.

• MalfunctionOct 22, 2019Component Missing; Component Missing

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THAT WHEN OPENING THE IMPLANT BOX (SEALED AND HERMETIC), THE NURSE DISCOVERED THE SCREW WAS MISSING INSIDE THE PACKAGE. THERE WAS NO CLINICAL CONSEQUENCE THIS REPORT IS FOR ONE (1) STERILE LATARJET SCREW, 40MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9218465 ↗