PlusDrive 400.054ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587042176), received between Dec 28, 2017 and Feb 19, 2020 — classified as 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE SURGEON RECEIVED A PACKAGE ON AN UNKNOWN DATE. HOWEVER, THE TITANIUM (TI) CORTEX SCREW THAT WAS SUPPOSED TO BE IN THE PACKAGE WAS NOT INSIDE IT. PACKAGE WAS SEALED BUT THE PRODUCT WAS NOT IN THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9728519 ↗
• MalfunctionDec 28, 2017Break; Break

  IT WAS REPORTED THAT DURING A LEFORT1/ BILATERAL SAGITTAL SPLIT OSTEOTOMY (BSSO) PROCEDURE, WHILE USING A BALL POINT DRIVER (BPD) SCREWDRIVER TO INSERT A 1.5 MM SELF-DRILLING SCREW INTO THE MAXILLA, THE SCREW HEAD SEPARATED FROM THE STEM OF THE SCREW. THE STEM OF THE SCREW REMAINS INTACT IN THE PATIENT. THERE WAS NO APPARENT HARM TO THE PATIENT AND NO DELAY IN THE CASE. THE HEAD OF THE SCREW COULD NOT BE FOUND AT THE TIME. CONCOMITANT DEVICE(S) REPORTED: SCREWDRIVER BLADE (PART 313.252, LOT UNKNOWN, QUANTITY 1); BATTERY POWERED DRIVER (PART 05.000.008, LOT UNKNOWN, QUANTITY 1); STERILE BATTERY (PART 05.000.007.01S, LOT UNKNOWN, QUANTITY 1). (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7151143 ↗