OsteoVation 390-0005Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813845020023), received between Apr 15, 2020 and Apr 15, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• MalfunctionApr 15, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ON (B)(6) 2020 OSTEOMED WAS NOTIFIED OF A PATIENT PRESENTING OPEN WOUNDS ON SURGICAL SITE (RIGHT ANKLE). PATIENT HAS HAD 4 SURGERIES IN THE PAST YEAR ON THE ANKLE. THE PATIENT DID ORIGINALLY HAVE OSTEOMED SCREWS IN THE RIGHT ANKLE AND THE DOCTOR FELT THERE MAY NEED TO BE A REVISION AND AN ADDITION OF A PLATE FOLLOWING THE 3RD SURGERY. THE REVISION WAS NOT DUE TO A COMPLAINT OR ISSUE WITH OSTEOMED SCREWS IMPLANTED. THERE WERE NO ISSUES TO REPORT ON THE PRODUCTS; THE PATIENT HAD SEPARATION AND ISSUES HEALING UNRELATED TO THE SURGERY OR THE SCREWS. ON (B)(6) THE SCREWS WERE REMOVED AND THE EXTREMILOCK ANKLE PLATING SYSTEM WAS IMPLANTED ALONG WITH THE OSTEOVATION PRODUCT. OSTEOVATION EX 5CC, INJECT FORMULA (PART 390-0005) WAS USED TO BACKFILL A VOID, DUE TO MISSING BONE. OSTEOVATION WAS NOT SETTING IN A TIMELY MANNER AND THE SALES REPRESENTATIVE IN THE SURGERY TRIED TO CONTACT OSTEOMED SALES SUPPORT. THE PRODUCT MANAGER HELPED TROUBLESHOOT SOME STEPS TO HELP SETTING. WARM COMPRESSION WITH WARM SALINE FOR ABOUT 10 MINUTES WERE USED. THEN, LOWERED TUNICATE WAS USED TO INCREASE HEAT. OSTEOVATION BEGAN TO SET AND 2 DOCTORS MADE THE DECISION TO CLOSE AFTER THE OSTEOVATION WAS NO LONGER RUNN

  Patient problems: Unspecified Infection

  MAUDE report 9965300 ↗