MONARCH 277030105Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034196602), received between Nov 21, 2019 and Nov 21, 2019 — classified as 1 malfunction.

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.

• MalfunctionNov 21, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT A POSTERIOR LUMBAR SPINAL FUSION (L2-SAI) TREATING DEGENERATIVE DISEASE ON (B)(6) 2019. THE SURGEON TRIED TO REMOVE A FORMERLY IMPLANTED CFS7.0-45MM SCREW ON L3 LEFT AND IMPLANT A CFS8.0-45MM SCREW INSTEAD. BECAUSE THE NEW SCREW SEEMED TIGHT (STICKING OUT APPROXIMATELY 2MM THAN EXPECTED), THE SURGEON TRIED TO REMOVE IT. THEN, THE FOLLOWING EVENTS OCCURRED IN SEQUENCE: THE TIP OF THE DRIVER SHAFT BROKE. AS THE SURGEON TRIED TO REMOVE THE SCREW BY FIXING A ROD AND A SETSCREW, THE SCREW HEAD OF THE CORTICAL FIX SCREW CAME OFF. THE ROD HOLDER BROKE. THE SURGEON DECIDED TO LEAVE THE FRAGMENTED CORE OF THE CORTICAL FIX SCREW IN THE PATIENT¿S BODY DUE TO THE LIMITED SURGICAL TIME. SINCE L3 LEFT WAS NOT FIXED, THE SCREW STABILIZATION HAS DECREASED A LITTLE. THE PATIENT IS RECOVERING. CONCOMITANT DEVICES: SETSCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN), ROD (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A FORCEPT ROD HOLDER, STRAIGHT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9355526 ↗