MONARCH 177470600Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034062532), received between Jul 10, 2020 and Jul 10, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 16, 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.

• InjuryJul 10, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON PUT ON A REVISION SURGERY WHERE A BROKEN ROD WAS SUSPECTED IN A T10-PELVIS CONSTRUCT THAT WAS ORIGINALLY IMPLANTED ON ''(B)(6) 201'' WHEREIN A SINGLE 5.5X600MM ROD WAS CUT TO MAKE 2 RODS. ONCE THE CONSTRUCT WAS EXPOSED, THE ROD WAS IDENTIFIED TO BE BROKEN ON BOTH SIDES OF THE CONSTRUCT. A PSEUDOARTHROSIS WAS DICTATED AS THE REASON FOR THE HARDWARE BREAKAGE. ELEVEN (11) EXPEDIUM SCREWS WERE REMOVED (DUE TO LOOSENING CAUSED BY THE PSEUDOARTHROSIS) AND REPLACED WITH NEW RODS AND CONNECTORS. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SET SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWELVE (12) DEVICES. THIS REPORT IS FOR (1) MON ROD, 5.5MM X 600MM, TI. THIS IS REPORT 1 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10261080 ↗