BMAN Solid Diamond Needle SR07-1100Recalls & reported problems
Surgentec, LLC · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810131880941), received between Mar 18, 2026 and Mar 18, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2026Material Integrity Problem
REP STATED THAT THE DOCTOR IMPACTED THE B-MAN INTO THE CORTICAL BONE OF THE ILIAC CREST TO PIERCE THE CORTEX. HE CONTINUED WITH THE ASPIRATION PROCEDURE AND WHEN HE REMOVED THE NEEDLE, HE NOTICED THAT THE TIP WAS NOT ATTACHED TO THE B-MAN CANNULA. THEY TOOK AN X-RAY AND DETERMINED IT REMAINED IN THE ILIUM. THE REP EXPRESSED THAT THE DOCTOR DID NOT STRIKE THE INSTRUMENT EXCESSIVELY AND DID NOT USE EXCESSIVE FORCE WHILE WORKING WITH THE INSTRUMENT. REP ALSO STATED THAT THIS DID NOT CAUSE THE PATIENT TO STAY UNDER ANESTHESIA LONGER THAN ORIGINALLY ANTICIPATED.
Patient problems: Foreign Body In Patient
MAUDE report 24630079 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.