N/A 6134.0045Recalls & reported problems
Globus Medical, Inc. · 4.5mm Cannulated Tap · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889095178104), received between Mar 1, 2024 and Apr 29, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Material Separation1
Patient problems
- Insufficient Information2
- Spinal Column Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A CASE THE TIP OF THE CANNULATED TAP BROKE OFF AND WAS RETAINED IN THE PATIENT'S VERTEBRAL BODY POST OPERATIVELY. THIS EVENT OCCURRED IN HONG KONG.
Patient problems: Spinal Column Injury
MAUDE report 19203685 ↗MalfunctionMar 4, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY THE TIP OF A CANNULATED TAP SHEARED OFF AND LEFT FRAGMENTS IN THE PATIENT. THE FRAGMENTS WERE RECOVERED DURING A REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 18832865 ↗MalfunctionMar 1, 2024Material Separation; Material Separation
IT WAS REPORTED THAT DURING SURGERY THE DISTAL TIP OF THE CREO MIS CANNULATED TAP BROKE OFF IN VERTEBRAL BODY AND WAS LEFT IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 18818618 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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.
How reports and recalls are matched · Editorial policy · Report an error on this page