PlusDrive 401.062ERecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10887587046037), received between Aug 2, 2022 and Aug 2, 2022 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE PATIENT INQUIRING ABOUT RECALLS ON PARTS USED ON A TOTAL LEFT TMJ REPLACEMENT DONE ON (B)(6) 2011. PATIENT HAVE ATTACHED SCREEN SHOTS OF THE INFORMATION HE HAVE. HIS JAW HAS MOVED OVER TO THE RIGHT NOW, IT¿S HARD TO CHEW AND NOBODY WANTS TO TOUCH IT BECAUSE THEY AREN¿T THE ORIGINAL SURGEON. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1)2.0MM TI CORTEX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 5MM THIS IS REPORT 10 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Nerve Damage; Unspecified Musculoskeletal problem

  MAUDE report 15147039 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE PATIENT INQUIRING ABOUT RECALLS ON PARTS USED ON A TOTAL LEFT TMJ REPLACEMENT DONE ON (B)(6) 2011. PATIENT HAVE ATTACHED SCREEN SHOTS OF THE INFORMATION HE HAVE. HIS JAW HAS MOVED OVER TO THE RIGHT NOW, IT¿S HARD TO CHEW AND NOBODY WANTS TO TOUCH IT BECAUSE THEY AREN¿T THE ORIGINAL SURGEON. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1)2.0MM TI CORTEX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 5MM. THIS IS REPORT 8 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Nerve Damage; Unspecified Musculoskeletal problem

  MAUDE report 15147032 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE PATIENT INQUIRING ABOUT RECALLS ON PARTS USED ON A TOTAL LEFT TMJ REPLACEMENT DONE ON (B)(6) 2011. PATIENT HAVE ATTACHED SCREEN SHOTS OF THE INFORMATION HE HAVE. HIS JAW HAS MOVED OVER TO THE RIGHT NOW, IT¿S HARD TO CHEW AND NOBODY WANTS TO TOUCH IT BECAUSE THEY AREN¿T THE ORIGINAL SURGEON. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1)2.0MM TI CORTEX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 5MM THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Nerve Damage; Unspecified Musculoskeletal problem

  MAUDE report 15147031 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE PATIENT INQUIRING ABOUT RECALLS ON PARTS USED ON A TOTAL LEFT TMJ REPLACEMENT DONE ON (B)(6) 2011. PATIENT HAVE ATTACHED SCREEN SHOTS OF THE INFORMATION HE HAVE. HIS JAW HAS MOVED OVER TO THE RIGHT NOW, IT¿S HARD TO CHEW AND NOBODY WANTS TO TOUCH IT BECAUSE THEY AREN¿T THE ORIGINAL SURGEON. THERE IS NO FURTHER INFORMATION THIS REPORT IS FOR ONE (1)2.0 MM TI CORTEX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 5 MM THIS IS REPORT 5 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Nerve Damage; Unspecified Musculoskeletal problem

  MAUDE report 15146641 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE PATIENT INQUIRING ABOUT RECALLS ON PARTS USED ON A TOTAL LEFT TMJ REPLACEMENT DONE ON (B)(6) 2011. PATIENT HAVE ATTACHED SCREEN SHOTS OF THE INFORMATION HE HAVE. HIS JAW HAS MOVED OVER TO THE RIGHT NOW, IT¿S HARD TO CHEW AND NOBODY WANTS TO TOUCH IT BECAUSE THEY AREN¿T THE ORIGINAL SURGEON. THERE IS NO FURTHER INFORMATION THIS REPORT IS FOR ONE (1)2.0MM TI CORTEX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 5MM THIS IS REPORT 6 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Nerve Damage; Unspecified Musculoskeletal problem

  MAUDE report 15146614 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE PATIENT INQUIRING ABOUT RECALLS ON PARTS USED ON A TOTAL LEFT TMJ REPLACEMENT DONE ON DEC 2011. PATIENT HAVE ATTACHED SCREEN SHOTS OF THE INFORMATION HE HAVE. HIS JAW HAS MOVED OVER TO THE RIGHT NOW, IT¿S HARD TO CHEW AND NOBODY WANTS TO TOUCH IT BECAUSE THEY AREN¿T THE ORIGINAL SURGEON. THERE IS NO FURTHER INFORMATION THIS REPORT IS FOR ONE (1)2.0MM TI CORTEX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 5MM THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Nerve Damage; Unspecified Musculoskeletal problem

  MAUDE report 15146448 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE PATIENT INQUIRING ABOUT RECALLS ON PARTS USED ON A TOTAL LEFT TMJ REPLACEMENT DONE ON (B)(6) 2011. PATIENT HAVE ATTACHED SCREEN SHOTS OF THE INFORMATION HE HAVE. HIS JAW HAS MOVED OVER TO THE RIGHT NOW, IT¿S HARD TO CHEW AND NOBODY WANTS TO TOUCH IT BECAUSE THEY AREN¿T THE ORIGINAL SURGEON. THERE IS NO FURTHER INFORMATION THIS REPORT IS FOR ONE (1)2.0MM TI CORTEX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 5MM. THIS IS REPORT 3 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Nerve Damage; Unspecified Musculoskeletal problem

  MAUDE report 15146442 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE PATIENT INQUIRING ABOUT RECALLS ON PARTS USED ON A TOTAL LEFT TMJ REPLACEMENT DONE ON (B)(6) 2011. PATIENT HAVE ATTACHED SCREEN SHOTS OF THE INFORMATION HE HAVE. HIS JAW HAS MOVED OVER TO THE RIGHT NOW, IT¿S HARD TO CHEW AND NOBODY WANTS TO TOUCH IT BECAUSE THEY AREN¿T THE ORIGINAL SURGEON. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) 2.0MM TI CORTEX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 5MM. THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Nerve Damage; Unspecified Musculoskeletal problem

  MAUDE report 15146434 ↗