OsteoMed 218-1605Recalls & reported problems
Osteomed LLC · 1.6mm X 5mm Profile Zero Autodrive Screw · Class 2 · Implant
- 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 00845694034265), received between Mar 7, 2026 and Mar 7, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
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 7, 2026Material Fragmentation
IT WAS REPORTED IN AN EMAIL THAT, "THE SURGEON WAS USING OUR CRANIAL PLATING SYSTEM TO SECURE BONE FLAP POST CRANIOTOMY. WHEN UTILIZING OUR 1.6MM AUTO-DRIVE SCREWS TO SECURE OUR PLATES TO BONE FLAP THE SCREWS BROKE. THE SURGEON STATED THE "HEADS SIMPLY TWISTED OFF"."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24540401 ↗
Other Plate, cranioplasty, preformed, alterable devices
- OsteoMed 218-1604Osteomed LLC · Plate, cranioplasty, preformed, alterable1 recall6 reports
- NA 56-90614Stryker Leibinger GmbH & Co. KG · Plate, cranioplasty, preformed, alterable1 recall0 reports
- OsteoMed 218-1604-SP-10Osteomed LLC · Plate, cranioplasty, preformed, alterable1 recall0 reports
- NA 78-50030Stryker Leibinger GmbH & Co. KG · Plate, cranioplasty, preformed, alterable21 reports
- THINFLAP SYSTEM 91-6704Biomet Microfixation, Inc · Plate, cranioplasty, preformed, alterable19 reports
- NA 78-50040Stryker Leibinger GmbH & Co. KG · Plate, cranioplasty, preformed, alterable18 reports
- NA 78-10030Stryker Leibinger GmbH & Co. KG · Plate, cranioplasty, preformed, alterable13 reports
- NA 78-40040Stryker Leibinger GmbH & Co. KG · Plate, cranioplasty, preformed, alterable11 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.