OsteoMed 216-0307Recalls & reported problems
Osteomed LLC · Activation Wire, 82mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845694004466), received between Mar 16, 2023 and Jul 3, 2024 — classified as 1 injury, 1 malfunction.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED DURING A MANDIBULAR DISTRACTION SURGERY ON THE RIGHT MANDIBLE OF A PEDIATRIC PATIENT, THE RIGHT DISTRACTOR WAS SECURED WITH SCREWS. THE ACTIVATION WIRE WAS INSERTED TO ADJUST THE DISTRACTOR, BUT THE WIRE WOULD NOT TURN. THE RIGHT DISTRACTOR WAS REMOVED AND WAS TESTED BY THE SURGEON ONCE REMOVED BUT WOULD NOT WORK. THE SAME ACTIVATION WIRE WAS USED IN THE LEFT DISTRACTOR AND APPEARED TO "JAM" DURING THE SECOND TURN; HOWEVER, THEY WERE ABLE TO GET THE ACTIVATION WIRE TO WORK IN THE LEFT DISTRACTOR TO COMPLETE THE LEFT SIDED DISTRACTION. THE REPORTED ACTIVATION WIRE WAS LEFT IN THE LEFT DISTRACTOR IN ORDER TO CONTINUE TO COMPLETE THE COURSE OF THE PATIENT'S DISTRACTION PROTOCOL. ANOTHER DISTRACTOR WAS USED ON THE PATIENT'S RIGHT SIDE TO COMPLETE THE SURGERY. THIS ISSUE PROLONGED THE SURGERY BY THREE (3) HOURS. NO OTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19669425 ↗MalfunctionMar 16, 2023Break; Break
IT WAS REPORTED (EVENT DATE UNKNOWN) LOGIC JR ACTIVATION WIRE BROKE POST-OP ON THE RIGHT SIDE. BASED ON INFORMATION RECEIVED THE CASE HAS GONE WELL AND A GOOD OUTCOME HAS BEEN ACHIEVED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16560724 ↗
Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices
- DISTRACTION, INTERNAL 51-405-42-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR20 reports
- LEVEL ONE CMF 50-760-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR18 reports
- DISTRACTION, INTERNAL 51-563-30-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR13 reports
- LEVEL ONE CMF 50-797-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR13 reports
- LEVEL ONE CMF 50-777-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR11 reports
- DISTRACTION, INTERNAL 51-526-30-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- NA 04.315.125Synthes GmbH · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- DISTRACTION, INTERNAL 51-401-91-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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