1.5MM SYSTEM 91-6105X-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841036219499), received between Aug 2, 2022 and Mar 2, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 reports).

3 other recalls cover devices cleared under the same FDA submission (K121589, K121624); 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2023Fracture; Fracture

  IT IS REPORTED THAT DURING A PROCEDURE THAT THE SCREW HEAD FRACTURED OFF. NO FRAGMENTS WERE RETAINED BY THE PAITIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475519 ↗
• MalfunctionMar 2, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475514 ↗
• MalfunctionMar 2, 2023Fracture; Fracture

  IT IS REPORTED THAT DURING A PROCEDURE THAT THE SCREW HEAD FRACTURED OFF. NO FRAGMENTS WERE RETAINED BY THE PAITIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475512 ↗
• MalfunctionSep 30, 2022Fracture; Fracture

  IT IS REPORTED THAT THE SCREW FRACTURED DURING A PROCEDURE. NO PIECES OF THE IMPLANT WERE RETAINED BY THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15514062 ↗
• InjuryAug 2, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING FIXATION OF THE BONE FLAP, WHEN FIXING THE PLATES WITH SELF-DRILLING SCREWS, TWO HEADS OF THE SCREWS WERE FRACTURED. THE PLATE WAS IMMEDIATELY CHANGED IN POSITION AND DIFFERENT SCREWS WERE USED TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 15146284 ↗
• InjuryAug 2, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING FIXATION OF THE BONE FLAP, WHEN FIXING THE PLATES WITH SELF-DRILLING SCREWS, TWO HEADS OF THE SCREWS WERE FRACTURED. THE PLATE WAS IMMEDIATELY CHANGED IN POSITION AND DIFFERENT SCREWS WERE USED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15146239 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121589, K121624. One submission often covers many models, so check the product and lot details in each record.

• Z-1220-2017 · Jan 10, 2017 · Terminated
  1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
• Z-0137-2016 · Aug 6, 2015 · Terminated
  Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
• Z-0136-2016 · Aug 6, 2015 · Terminated
  Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.