NA SD480.110Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10887587005324), received between Mar 6, 2018 and Jul 18, 2022 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2022Defective Device; Defective Device

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PRIOR TO A MANDIBULAR RECONSTRUCTION PROCEDURE ON 22-JUNE-2022, IT WAS CONFIRMED BY THE SURGEON THAT THE CUSTOM-MADE DEVICES DID NOT CONFORM TO THE PATIENT¿S CT DATA. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI PATIENT SPECIFIC PLATE MANDIBLE/ANGLE/2.0MM THICK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15040995 ↗
• MalfunctionMar 23, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HUB OF THE CEREBASE CATHETER BROKE WHERE THE ORANGE AND YELLOW PIECE MEET. A BALLAST CATHETER WAS USED TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF THERE IS SURGICAL DELAY REPORTED. THERE WERE NO FRAGMENTS GENERATED. THIS REPORT INVOLVES ONE (1) TI PATIENT SPECIFIC PLATE MANDIBLE/ANGLE/2.0MM THICK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554093 ↗
• InjuryMar 1, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT MANDIBLE RESECTION. THE PLATE AND SCREWS WERE PLACED, AND A TITANIUM PATIENT SPECIFIC PLATE MANDIBLE WAS REMOVED. THE PATIENT WAS NOTED TO HAVE POOR BONE QUALITY. THERE WAS NO MALFUNCTION OF THE PLATE OR SCREWS. THE PATIENT HAD A FRACTURE AROUND THE PLATE AND SCREWS AND PROBABLE OSTEOMYELITIS. ONLY THE BONE AROUND THE HARDWARE FAILED. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) TI PATIENT SPECIFIC PLATE MANDIBLE/ANGLE/2.0MM THICK. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 8382490 ↗
• InjuryJul 17, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT MULTIPLE PATIENT SPECIFIC IMPLANTS MALFUNCTIONED. THE SURGERY WAS PERFORMED ON (B)(6) 2018. THE PROCEDURE WAS PERFORMED TO CORRECT HEMIFACIAL MICROSOMIA OF THE PATIENT. THERE WAS NOTHING WRONG WITH THE DEVICE BUT THE CASE WAS VERY COMPLICATED AND THE DEVICE DID NOT LINE UP WITH THE SURGEON'S PREFERENCE. THERE WAS NO DEFECT IN THE DEVICE. BOTH PLATES NEED TO BE SHORTER AS THEY EXTENDED TOO FAR TOWARD THE ANGLE AND THE BODY; THE PLATES WERE TOO THICK. THESE PLATES ULTIMATELY WERE NOT IMPLANTED. THERE WAS NO DELAY IN THE PROCEDURE AND THE PATIENT OUTCOME WAS FINE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7693676 ↗
• InjuryJul 17, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT MULTIPLE PATIENT SPECIFIC IMPLANTS MALFUNCTIONED. THE SURGERY WAS PERFORMED ON (B)(6) 2018. THE PROCEDURE WAS PERFORMED TO CORRECT HEMIFACIAL MICROSOMIA OF THE PATIENT. THERE WAS NOTHING WRONG WITH THE DEVICE BUT THE CASE WAS VERY COMPLICATED AND THE DEVICE DID NOT LINE UP WITH THE SURGEON'S PREFERENCE. THERE WAS NO DEFECT IN THE DEVICE. BOTH PLATES NEED TO BE SHORTER AS THEY EXTENDED TOO FAR TOWARD THE ANGLE AND THE BODY; THE PLATES WERE TOO THICK. THESE PLATES ULTIMATELY WERE NOT IMPLANTED. THERE WAS NO DELAY IN THE PROCEDURE AND THE PATIENT OUTCOME WAS FINE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7693649 ↗
• InjuryMar 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SURGEON TOOK OUT A TRUMATCH MANDIBULAR PLATE AND SEVEN LOCKING SCREWS FROM THE PATIENT ON (B)(6) 2018 DUE AN INFECTION AND NON-UNION. THE PATIENT WAS IMPLANTED WITH ONE (1) TRUMATCH MANDIBULAR PLATE AND (7) SEVEN LOCKING SCREWS ON (B)(6) 2017. THE PATIENT EXPERIENCED NON-UNION AND INFECTION POST-SURGERY AND THE SURGEON REMOVED ALL THE HARDWARE. THE HARDWARE REMOVAL WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT STATUS IS REPORTED TO BE FINE POST-SURGERY. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7318763 ↗