ACUMED 30-0348Recalls & reported problems
Acumed LLC · 2.7mm x 18mm Non-Locking Hexalobe Screw · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10806378018367), received between Sep 5, 2025 and May 15, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Fragmentation” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K122538); they may or may not involve this specific model.
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
- Material Fragmentation2
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2026Material Fragmentation
MW5186891 WAS RECEIVED BY ACUMED ON APRIL 17, 2026 WITH THE FOLLOWING REPORTED, "DURING SURGICAL OPEN REDUCTION INTERNAL FIXATION ACUMED SCREWS X 2 BROKE WHEN IMPLANTED INTO RIGHT ACUMED PLATE. REMNANTS LEFT IN RIGHT ULNA PER SURGEON DISCRETION. SCREWS 30-0348 2.7MM X 18MM AND 30-0328 2.7MM X 16MM. HECC: 2687. DPC: 1261, 1212. REF: MW5186892.."
Patient problems: Foreign Body In Patient
MAUDE report 25194475 ↗InjurySep 5, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE SCREW ALLEGEDLY BROKE AND IS LEFT IN THE PATIENT. THERE WAS A REPORTED 3 MINUTE DELAY, BUT NO FURTHER ADVERSE EFFECTS TO THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22977367 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K122538. One submission often covers many models, so check the product and lot details in each record.
- Z-1199-2017 · Jan 19, 2017 · Terminated6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fr
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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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