2.7MM SYSTEM 99-9950Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841036058562), received between Mar 6, 2019 and Mar 6, 2019 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K854886); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2019Adverse 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: Bacterial Infection

  MAUDE report 8394398 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K854886. One submission often covers many models, so check the product and lot details in each record.

• Z-0108-2011 · Aug 31, 2010 · Terminated
  2.0/1.0 4 hole long plate (titanium plate ).Lot 120150. Product labeling reads: (1. ) REF: 01-9205, Lot 999999, " 2.0MM" SYSTEM PLATE 4 HOLE PLATE, STRAIGHT, LONG. (2.) QTY