NA 449.110Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587054148), received between Mar 5, 2019 and Mar 5, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT WAS IMPLANTED WITH A TITANIUM COMPRESSION TENSION BAND PLATE AND SIX (6) TITANIUM (TI) CORTEX SCREWS. APPROXIMATELY NINE (9) DAYS AFTER IMPLANTATION, THE PATIENT RETURNED TO THE ORAL SURGERY OFFICE BECAUSE THEIR MANDIBLE FELT DISPLACED. IT WAS DISCOVERED THAT THE PLATE HAD BROKEN. CONCOMITANT DEVICES: TITANIUM CORTEX SCREW SELF-TAPPING (PART: 401.506E, LOT: UNKNOWN, QUANTITY: 6). THIS REPORT IS FOR A 2.4MM TI COMPRESSION TENSION BAND PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8390160 ↗