OsteoMed 214-0080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00845694003599), received between Dec 27, 2022 and Dec 27, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2022 WITH NO ISSUES POST-OP OR DURING CLINICAL FOLLOW UP UNTIL THE PATIENT STARTED REPORTING DISCOMFORT AROUND (B)(6) 2022 (EVENT DATE) AT WHICH TIME IMAGING SUGGESTED THE SCREW ON THE LEFT SIDE PLATE APPEARED OUT OF THE USUAL LOCATION. EXPLORATORY SURGERY WAS PERFORMED ON (B)(6) 2022 AND FOUND LOOSENING OF THE PLATE AND "SLIGHT MOVEMENT OF THE DISTAL STUMP". THE PATIENT WAS THEN REFERRED TO THE (B)(6) FOR EMERGENCY REMOVAL AND REFIXATION WHICH TOOK PLACE ON (B)(6) 2022. THE IMPRESSION WAS THAT THE MANDIBULLARY BONE HAD REABSORBED AROUND THE SCREWS AND GRANULATION TISSUE HAD FORMED AT THE SITE. BACTERIAL CULTURE OF MATERIAL COLLECTED REVEALED IT WAS NEGATIVE. IT WAS REPORTED "THEY WILL BE FORWARDING THE SCREWS REMOVED FROM THE PATIENT'S SECOND SURGERY"- PRESUMABLY, THE DEVICES EXPLANTED DURING THE REVISION ON (B)(6) 2022. IT WAS ALSO REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO PLATES AND SCREWS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 25 OF 57 FOR THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 16049457 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO THE IMPLANTED PLATES AND SCREWS. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 2 OF 40 FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 16049295 ↗
• InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO THE IMPLANTED PLATES AND SCREWS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16049293 ↗