n/a 3289002Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885074035994), received between Mar 15, 2017 and Mar 15, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Disassembly” (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.

• InjuryMar 15, 2017Disassembly; Appropriate Device Problem Term/Code Not Available; Disassembly; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON: (B)(6) 2016: PATIENT PRESENTED WITH INTERNAL DISRUPTION OF L5/S1 DISK WITH INTRACTABLE PAIN BACK AND BILATERAL LEGS RESPECTIVELY, STATUS POST DISCOGRAPHIC WORKUP. PATIENT UNDERWENT THE FOLLOWING PROCEDURE: ANTERIOR LUMBAR INTERBODY FUSION AT L5-S1 WITH RADICAL DISCECTOMY USING GRAFT SUPERCHARGED WITH RHBMP-2/ACS WITH FLUOROSCOPIC SUPERVISION DURING SAME, AND LEFT INTRA ABDOMINAL ILIAC VEIN REPAIR. PER-OP NOTES: ¿.. I PROCEEDED TO GRAFT THE L5-S1 SPACE WITH RGRAFT AS A CARRIER SUPERCHARGED WITH RHBMP-2/ACS.¿ INTRA-OPERATIVELY,THE HANDLE, WHICH WAS USED TO PLACE THE TEMPLATE, DISLODGED FROM THE TEMPLATE AND HIT THE PATIENT'S ILIAC VEIN, RESULTING IN A LACERATION OF THE ILIAC VEIN. THE HANDLE WAS USED TO PLACE THE TEMPLATE IN THE DISC PLACE, AS A MEASURING DEVICE, PRIOR TO THE INSERTION OF THE PERMANENT CAGE. ALLEGEDLY, "AS A RESULT OF THE LACERATION TO THE ILIAC VEIN, THE PATIENT LOST 4650 CC OF BLOOD BEFORE THE NEUROSURGEON AND A VASCULAR SURGEON IN THE OPERATIVE SUITE WERE ABLE TO REPAIR THE ILIAC VEIN AND STOP THE BLEEDING. BECAUSE OF THIS EVENT, THE CAGE LUMBAR FUSION WAS ABANDONED." REPORTEDLY, "FOLLOWING THE LACERATION OF THE ILIAC VEIN, A VALIANT ATTEM

  Patient problems: Blood Loss; Laceration(s)

  MAUDE report 6408505 ↗