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OsteoMed 330-1614Recalls & reported problems

Osteomed LLC · 1.6mm x 14mm Fully Threaded Screw, Angled Locking · Class 2

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 00845694023436), received between Mar 31, 2021 and Mar 31, 2021 — classified as 1 malfunction.

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

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • 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, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; 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 1141838)

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11600075 ↗

Other Screw, fixation, bone devices

All Screw, fixation, bone devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.