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NA 447.042Recalls & reported problems

Synthes GmbH · 2.0MM TI MAXILLARY L-PLATE 3 X 3 HOLES/27MM-RIGHT · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587052526), received between Aug 2, 2022 and Aug 2, 2022 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Nerve Damage1
  • Unspecified Musculoskeletal problem1

Recent adverse event reports

The 1 most recent of 1 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 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)2.0 TI MAXILLARY L-PL 3 X 3 HOLES/27-RT THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4).

    Patient problems: Nerve Damage; Unspecified Musculoskeletal problem

    MAUDE report 15147019 ↗

Other PLATE, BONE devices

All PLATE, BONE devices →

Sources and updates

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