SmartFrame CP-NGS-11-HC-SCMRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850359007034), received between Apr 24, 2017 and Apr 24, 2017 — classified as 1 injury.

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.

• InjuryApr 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TWIST DRILL WAS USED TO PREPARE 3.4 MM PILOT HOLE, FOLLOWED BY A 4.5 MM BIT TO PROVIDE LARGER ACCESS TO THE FRONTAL LOBE LESION. DURING BIOPSY OF THE LESION, IT WAS NOTED THAT THERE WAS A LARGER THAN NORMAL AMOUNT OF BLOOD. SUBSEQUENT MRI SCANS CONFIRMED SOME BLOOD IN THE SUBARACHNOID SPACE AND SUBDURAL. THE CASE WAS ABORTED. PATIENT WAS REMOVED FROM THE MRI SCANNER, INTO THE OPERATING ROOM FOR A CRANIOTOMY TO REMOVE THE BLOOD. ON THE SUBSEQUENT FRIDAY THE (B)(6), PATIENT PRESENTED HEMIPLEGIC, WITH RE-ACCUMULATION OF BLOOD VISIBLE ON CT, SO A SECOND CRANIOTOMY WAS PERFORMED. THE PATIENT IS DOING WELL, WITH NO EXPECTED CONTINUED DEFICIT.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 6517011 ↗