OsteoMed 338-2718Recalls & reported problems
Osteomed LLC · 2.7mm x 18mm Double-Lead Locking Screw, T8 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845694042598), received between Aug 5, 2021 and Aug 5, 2021 — classified as 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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Discomfort1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2021Break; Break
ON JULY 08, 2021 OSTEOMED WAS NOTIFIED THAT, DURING A FOLLOW UP VISIT DUE TO DISCOMFORT ON THE LEFT FOOT OF THE PATIENT; THE X-RAY'S FROM (B)(6) 2021 REFLECTS THAT THE PLATE IMPLANTED ON (B)(6) 2020 WAS BROKEN. PER THE REPORTER: "THE PATIENT PRESENTED DISCOMFORT AND AT THE TIME OF THE REVIEW IT WAS DETECTED THAT THE PLATE (336-2710) HAD FRACTURED, THE DOCTOR INDICATES THAT HE HAS NO SIGNS THAT THE PATIENT HAS EXPOSED THE PLATE TO FATIGUE." THE INVOLVED PART NUMBERS ARE AS FOLLOWS: PART NUMBER, DESCRIPTION, LOT #, QUANTITY, 336-2710, 2.7 MM 10 HOLE SUBCONDYLAR PLATE, 1139811, 1; 338-2710, 2.7 X 10MM FULLY THREADED ANGLED LOCKING, 1129481, 2; 338-2712, 2.7 X 12MM FULLY THREADED ANGLED LOCKING, 1129482, 1; 338-2716, 2.7 X 16MM FULLY THREADED ANGLED LOCKING, 1128465, 1; 338-2718, 2.7 X 18MM FULLY THREADED ANGLED LOCKING, 1136613, 1.
Patient problems: Discomfort
MAUDE report 12285240 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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