OsteoMed 333-1603Recalls & reported problems
Osteomed LLC · 1.6mm Y Plate, Locking · Class 2 · Implant
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 00845694024839), received between Mar 31, 2021 and Mar 31, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device1
- Device Difficult to Setup or Prepare1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2021Device Difficult to Setup or Prepare; Defective Device; Insufficient Device Problem Information; Device Difficult to Setup or Prepare; Defective Device; Insufficient Device Problem Information
ON FEBRUARY 25, 2021 OSTEOMED WAS NOTIFIED THAT, DURING AN IMPLANT OF A 1.6MM, 3 X 8 HOLES, "Y" PLATE (PART 333-1603/LOT 1145750) TWO (2) OF THE FOUR (4) SCREWS USED DID NOT LOCK IN THE PLATE. THESE 2 SCREWS WERE IDENTIFIED AS 1.6MM X 14MM FULL THREADED SCREW, LOCKING (PART 330-1614/LOT 1141838) AND 1.6MM X 16MM FULL THREADED SCREW, LOCKING (PART 330-1616 /LOT 1130797). THE IMPLANT AND EXPLANT OCCUR ON (B)(6) 2021 DURING THE SAME SURGERY. ON MARCH 02, 2021, OSTEOMED WAS NOTIFIED THAT, THE SURGERY WAS PROLONGED FOR ONE HOUR AND THE PATIENT HAD NO CONSEQUENCES OR IMPACT.PER THE REPORTER: "DURING THE PROCEDURE, THE SPECIALIST ASKS ME FOR A HPS 1.6 AV BLOCK Y PLATE WITH 11 HOLES (REF. 333-1603, BATCH 1145750) FROM SET 0056. THE SPECIALIST ASKED ME TO CUT IT AND I LEFT IT WITH 4 HOLES IN THE BRANCH. AFTER, PLACING THE PLATE ON THE BONE THE SPECIALIST FIXES IT WITH A STANDARD CRUCIFORM 1.6X10MM HPS SCREW (REF. 331-1610, BATCH. 1148546) AND A 1.6X8MM AV HPS LOCKED SCREW (REF. 330-1608, LOT. 1141744), ON THE BRANCH. THEN, HE ASK ME FOR A DRILL TO DRILL THE PROXIMAL HOLE OF THE Y-PLATE. THE SPECIALIST MEASURES AND ASKS ME FOR A 1.6X14MM AV. HPS LOCKED SCREW, (REF. 330-1614, BATCH 1141
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11600030 ↗
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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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