Matrixx System 54M-26-08-SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889929020258), received between Oct 19, 2018 and Oct 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2018Fracture; Fracture

  IT WAS REPORTED ON (B)(6) 2018 DURING A SPINAL PROCEDURE A MATRIXX IMPLANT FRACTURED WHILE THE SURGEON WAS TRYING TO ROTATE INTO PLACEMENT. THE SURGEON WAS PUSHING THE IMPLANT BEYOND EXPECTATION AND CAUSED AN EXTREME LOAD AND THE IMPLANT FRACTURED. IT SHOULD BE NOTED, THE TORQUE APPLIED TO THE IMPLANT WAS GREATER THAN THE DESIGN LIMIT.75% TO 80% OF THE DEVICE IS IMPLANTED IN THE DISC SPACE AND THE REMAINDER OF THE DEVICE WAS NOT IMPLANTED AS IT WAS ATTACHED TO THE INSERTING INSTRUMENT. AT NO TIME DURING THE PROCEDURE, DID A FRACTURED PIECE FALL INTO THE PATIENT'S WOUND. THE SURGEON INVESTIGATED AND FOUND THE IMPLANT TO BE SECURE AND WAS PERFORMING AS INTENDED SO IT WAS DECIDED TO LEAVE THE IMPLANT IN PLACE. THERE WAS NO PATIENT INJURY DUE TO THE EVENT. THE REMAINDER OF THE IMPLANT WAS LOST BY THE CENTRAL PROCESSING CENTER AT THE HOSTPITAL AND WILL NOT BE RETURNED TO NEXXT SPINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7984992 ↗