VertecoR® 00884450296325Recalls & reported problems
Merit Medical Systems, Inc. · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00884450296325), received between Nov 3, 2021 and Nov 3, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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
Device problems
- Material Separation1
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.
MalfunctionNov 3, 2021Material Separation; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PROCEDURE A BONE DRILL TIP DETACHED WITHIN THE PATIENT'S SPINE. THE TIP WAS EVENTUALLY ENCAPSULATED AND WAS NOT PROTRUDING OR CAUSING PATIENT DISCOMFORT. THE FOREIGN BODY IS STILL WITHIN THE PATIENT'S SPINE, THERE ARE NO PLANS TO EXPLANT THE FOREIGN BODY. "NOTHE" ACCOUNT ALLEGES THAT DURING A PROCEDURE A BONE DRILL TIP DETACHED WITHIN THE PATIENT'S SPINE. THE TIP WAS EVENTUALLY ENCAPSULATED AND WAS NOT PROTRUDING OR CAUSING PATIENT DISCOMFORT. THE FOREIGN BODY IS STILL WITHIN THE PATIENT'S SPINE, THERE ARE NO PLANS TO EXPLANT THE FOREIGN BODY. NO CHANCE OF MIGRATION, OR INJURY. PATIENT DOING WELL AND PHYSICIAN I SNOT INTERESTED IN INTERVENTION. THE PATIENT AGE WAS TAKEN INTO CONSIDERATION.
Patient problems: Foreign Body In Patient
MAUDE report 12747434 ↗
Other BIT, DRILL devices
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 reports
- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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