PlusDrive 400.056ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587042237), received between Jan 17, 2024 and Jan 17, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionJan 17, 2024Break; Break

  IT WAS REPORTED THAT DURING A NEUROSURGERY PROCEDURE ON (B)(6)2023, THE 1.5 X 6MM SCREWS WERE BEING PUT INTO A PEEK PSI (PATIENT SPECIFIC IMPLANT) AND BROKE. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY. THE FRAGMENTS WERE EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. THIS REPORT INVOLVES ONE 1.5MM TI CORTEX SCR SLF-DRLG WITH PLUSDRIVE(TM) RECESS 6MM. THIS IS REPORT 1 OF 2 FOR (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18526007 ↗
• MalfunctionJan 17, 2024Break; Break

  IT WAS REPORTED THAT DURING A NEUROSURGERY PROCEDURE ON (B)(6) 2023, THE 1.5 X 6MM SCREWS WERE BEING PUT INTO A PEEK PSI (PATIENT SPECIFIC IMPLANT) AND BROKE. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY. THE FRAGMENTS WERE EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. THIS REPORT INVOLVES ONE 1.5MM TI CORTEX SCR SLF-DRLG WITH PLUSDRIVE(TM) RECESS 6MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18525998 ↗