1.5MM SYSTEM 91-6104-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841036219505), received between Feb 13, 2020 and Dec 31, 2020 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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.

• InjuryDec 31, 2020Fracture; Fracture

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

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11102061 ↗
• MalfunctionDec 29, 2020Fracture; Fracture

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11089301 ↗
• MalfunctionDec 29, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO (2) SCREW HEADS SHEARED OFF WHILE FIXING A PLATE. THE SCREW HEADS WERE DESCRIBED AS MALLEABLE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11089288 ↗
• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CUSTOM CRANIOPLASTY PLATE WAS REMOVED DUE TO NECROSIS TWO (2) MONTHS AFTER IMPLANTATION. A FEW DAYS AFTER SURGERY, A BRUISE WAS OBSERVED IN THE SKIN OVER THE MIDDLE OF THE IMPLANT, AND THE BRUISE DID NOT IMPROVE. TWO (2) WEEKS PRIOR TO REMOVAL, THE SPOT ON THE SKIN OPENED UP WITH FLUID ESCAPING. IT HAS NOT BEEN DETERMINED IF THE BACK-UP IMPLANT WILL BE USED OR IF A NEW CUSTOM PLATE WILL BE IMPLANTED IN THE COMING MONTHS. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Bruise/Contusion; Fluid Discharge; Necrosis

  MAUDE report 10475095 ↗
• InjuryJun 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 10180030 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WILL UNDERGO A REVISION OF A CUSTOM CRANIAL PLATE DUE TO UNSPECIFIED MEDICAL ISSUES. THE CUSTOM CRANIAL IMPLANT WILL BE REMOVED AND WILL BE REPLACED WITH A NEW CUSTOM CRANIAL IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 9709341 ↗

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-0136-2016 · Aug 6, 2015 · Terminated
  Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
• Z-0137-2016 · Aug 6, 2015 · Terminated
  Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.