Arsenal 87107-055Recalls & reported problems
Alphatec Spine, Inc. · 5.5mm TAP · Class 1
All models of Arsenal (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840967126838), received between Feb 21, 2019 and Feb 11, 2020 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (5 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.
Most reported problems
Device problems
- Break5
- Detachment of Device or Device Component1
Patient problems
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2020Break
TAP WAS IN THE PEDICLE AND SURGEON FORCED DOWN AT AN ANGLE CAUSING IT TO BREAK. THE EVENT CAUSED NO PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9694012 ↗MalfunctionDec 10, 2019Break
SURGEON WAS TAPPING INTO BONE AND IT SNAPPED RIGHT ABOVE THE THREADS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9444000 ↗MalfunctionMay 29, 2019Break
WHILE TAPPING THE PEDICLE, THE 5.5MM TAP BROKE. THE SURGEON REMOVED THE THREADED TIP FROM THE PATIENTS BONE AND THE SURGERY COMPLETED WITHOUT FURTHER ISSUE. THE EVENT CAUSED NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8649801 ↗MalfunctionMar 1, 2019Break; Detachment of Device or Device Component
WHILE TAPPING THE PEDICLE, THE 5.5MM TAP BROKE. THE DETACHED SECTION WAS RETRIEVED FROM THE PATIENT AND THE SURGERY COMPLETED WITHOUT FURTHER ISSUE. THE EVENT CAUSED NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8381969 ↗MalfunctionFeb 21, 2019Break
WHILE TAPPING THE PEDICLE, THE 5.5MM TAP BROKE. THE DETACHED SECTION WAS RETRIEVED FROM THE PATIENT AND THE SURGERY COMPLETED WITHOUT FURTHER ISSUE. THE EVENT CAUSED NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8357653 ↗
Other TAP, BONE devices
- NA 311.43Synthes GmbH · TAP, BONE176 reports
- NA 311.01Synthes GmbH · TAP, BONE106 reports
- NA 311.431Synthes GmbH · TAP, BONE70 reports
- NA 03.424.124Synthes GmbH · TAP, BONE1 recall7 reports
- NA 03.424.126Synthes GmbH · TAP, BONE1 recall0 reports
- A.L.P.S.® 8241-50-170Biomet Orthopedics, LLC · TAP, BONE1 recall0 reports
- N/A 876-474Medtronic Sofamor Danek, Inc. · TAP, BONE1 recall0 reports
- NA 311.44Synthes GmbH · TAP, BONE41 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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