MEDPOR 6648Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 37613252088463), received between Nov 6, 2019 and Nov 6, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K833586); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2019Break; Fracture; Detachment of Device or Device Component; Fracture

  IT WAS REPORTED BY A DISTRIBUTOR THAT AFTER AN INITIAL SURGERY WAS COMPLETED A REVISION SURGERY TOOK PLACE TO REMOVE A DRAIN THAT BROKE OFF INSIDE A PATIENT'S KNEE. THE INITIAL SURGERY WAS REPORTED AS COMPLETED SUCCESSFULLY, AND THERE IS NO FURTHER INFORMATION AVAILABLE REGARDING THE REVISION SURGERY.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 9284203 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K833586. One submission often covers many models, so check the product and lot details in each record.

• Z-1150-2017 · Jan 3, 2017 · Terminated
  9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 P
• Z-1149-2017 · Jan 3, 2017 · Terminated
  QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System