TYRX™ Neuro Absorbable Antibacterial Envelope - Medium NMRM6122Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169624788), received between Dec 7, 2017 and Apr 8, 2019 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Expiration Issue” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2019Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION FOLLOWING IMPLANT OF AN ANTIBACTERIAL ENVELOPE. THE ENVELOPE WAS REMOVED AND DISCARDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8491598 ↗
• InjuryMar 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S INCISION HAS OPENED UP, WOUND DEHISCENCE PRESENT. THE ABSORBABLE ANTIBACTERIAL ENVELOPE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Wound Dehiscence

  MAUDE report 7342312 ↗
• InjuryMar 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT DEVELOPED A POCKET INFECTION OR HAD A REACTION POST IMPLANT OF THE ANTIBACTERIAL ENVELOPE. IT WAS ALSO REPORTED WHEN THE ENVELOPE WAS IMPLANTED ¿A NEW PRODUCT WAS WRAPPED AROUND IT.¿ THE PATIENT UNDERWENT EXPLANT OF THE SYSTEM. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE, BUT NOT RECEIVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Reaction; Unspecified Infection

  MAUDE report 7341270 ↗
• MalfunctionDec 7, 2017Device Expiration Issue; Device Expiration Issue

  IT WAS REPORTED AN ANTIBACTERIAL ENVELOPE WAS IMPLANTED EIGHT DAYS PAST THE EXPIRATION DATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7093584 ↗