TYRX™ Neuro Absorbable Antibacterial Envelope - Large NMRM6133Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169624795), received between Dec 9, 2016 and Oct 3, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 3, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT THAT HAD A DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTED ALONG WITH A ABSORBABLE ANTIBACTERIAL ENVELOPE. THE PATIENT HAD REPORTED DISCOMFORT AT THE AT THE IMPLANT SITE AND APPROXIMATELY NINE MONTHS POST IMPLANT A POCKET REVISION WAS COMPLETED. WHEN THE SURGEON OPENED THE INCISION THEY FOUND THAT THE ABSORBABLE ANTIBACTERIAL ENVELOPE HAD FUSED TO THE UNDERLYING TISSUE. THE SURGEON HAD TO CUT AWAY THE TISSUE AND EXTENSION IN ORDER TO REMOVE THE ENVELOPE. THE IPG WAS PLACED BACK INTO THE POCKET AND AN ANTIBIOTIC POWDER WAS PLACED IN THE POCKET AND THE INCISION WAS CLOSED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Tissue Damage

  MAUDE report 7930662 ↗
• InjuryJun 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS AFTER IMPLANT THE PATIENT DEVELOPED A POCKET INFECTION. THE ABSORBABLE ANTIBACTERIAL ENVELOPE WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 6624725 ↗
• MalfunctionDec 9, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE ABSORBABLE ENVELOPE WAS OPENED AND FOUND TO HAVE A VISIBLE ANOMALY ON THE ENVELOPE, A BLACK SPEC. THE ENVELOPE WAS INSPECTED BEFORE GOING TO THE STERILE FIELD BY THE IMPLANTING PHYSICIAN WHO DETERMINED IT SHOULD BE DISCARDED. ANOTHER ENVELOPE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6164742 ↗