Response 5.5/6.0 Spine System 01-1300-6000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841132152027), received between Feb 17, 2020 and Mar 20, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

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.

• MalfunctionMar 20, 2020Fracture; Fracture

  IT HAS BEEN REPORTED THAT DURING THE INSPECTION OF A ROD REDUCER, IT WAS FOUND TO BE FRACTURED. THE LOCATION OF THE FRAGMENTED COMPONENT IS UNKNOWN. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9862384 ↗
• MalfunctionMar 4, 2020Fracture; Fracture

  IT HAS BEEN REPORTED THAT DURING THE INSPECTION OF A ROD REDUCER, IT WAS FOUND TO BE FRACTURED. THE LOCATION OF THE FRAGMENTED COMPONENT IS UNKNOWN. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9788358 ↗
• MalfunctionMar 4, 2020Fracture; Fracture

  IT HAS BEEN REPORTED THAT DURING THE INSPECTION OF A ROD REDUCER, IT WAS FOUND TO BE FRACTURED. THE LOCATION OF THE FRAGMENTED COMPONENT IS UNKNOWN. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9788351 ↗
• InjuryFeb 17, 2020Fracture; Fracture

  IT HAS BEEN REPORTED THAT DURING CLOSURE OF A POSTERIOR SPINAL FUSION PROCEDURE, A TAB WAS IDENTIFIED TO BE MISSING FROM A ROD REDUCER. FLUOROSCOPY IDENTIFIED THAT THE TAB REMAINED IN THE PATIENT. BONE GRAFT WAS REMOVED AND THE FRACTURED PIECE WAS RECOVERED. BONE GRAFT WAS REPLACED AND INCISION CLOSED. A DELAY GREATER THAN THIRTY MINUTES WAS NOTED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9717724 ↗