PlusDrive 401.045Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20887587045785), received between Jun 20, 2018 and Jun 20, 2018 — classified as 2 injuries.

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.

• InjuryJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2014 THE PATIENT HAD SURGERY FOR DEBRIDEMENT OF INTRAORAL WOUND/INFECTION AND REMOVAL OF BONE AND NEW HARDWARE DUE TO INCREASE PAIN AND LOSS OF THE SKIN PADDLE OF FLAP AND EXPOSED. TWO (2) 4 HOLE MINI LOCKING PLATES WERE REMOVED AND ONE (1) 2.0MM TI CORTEX SELF-TAPPING AND TWO (2) 2.0MM TI CORTEX COARSE PITCH SELF-TAPPING WERE REMOVED DURING HARDWARE REMOVAL SURGERY. THE PATIENT'S ORIGINAL IMPLANT DATE WAS (B)(6) 2014. THIS COMPLAINT ADDRESSES THE SECOND REVISION SURGERY DUE INTRAORAL WOUND/INFECTION AND DUE TO INCREASE PAIN AND LOSS OF THE SKIN PADDLE OF FLAP AND EXPOSED. THE FIRST REVISION DUE TO BROKEN MANDIBULAR PLATE HAS BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). THIRD SURGERY FOR BONE TRANSPLANT AND REPLACEMENT OF HARDWARE DUE TO UNKNOWN REASON HAS BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 2.0MM TI CORTEX SCREW COARSE PITCH SLF-TPNG W/PLUSDRIVE(TM) 10MM. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7623352 ↗
• InjuryJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2014 THE PATIENT HAD SURGERY FOR DEBRIDEMENT OF INTRAORAL WOUND/INFECTION AND REMOVAL OF BONE AND NEW HARDWARE DUE TO INCREASE PAIN AND LOSS OF THE SKIN PADDLE OF FLAP AND EXPOSED. TWO (2) 4 HOLE MINI LOCKING PLATES WERE REMOVED AND ONE (1) 2.0MM TI CORTEX SELF-TAPPING AND TWO (2) 2.0MM TI CORTEX COARSE PITCH SELF-TAPPING WERE REMOVED DURING HARDWARE REMOVAL SURGERY. THE PATIENT'S ORIGINAL IMPLANT DATE WAS (B)(6) 2014. THIS COMPLAINT ADDRESSES THE SECOND REVISION SURGERY DUE INTRAORAL WOUND/INFECTION AND DUE TO INCREASE PAIN AND LOSS OF THE SKIN PADDLE OF FLAP AND EXPOSED. THE FIRST REVISION DUE TO BROKEN MANDIBULAR PLATE HAS BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). THIRD SURGERY FOR BONE TRANSPLANT AND REPLACEMENT OF HARDWARE DUE TO UNKNOWN REASON HAS BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 2.0MM TI CORTEX SCREW COARSE PITCH SLF-TPNG W/PLUSDRIVE(TM) 10MM. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7623318 ↗