ES2 SPINAL SYSTEM 48280155Recalls & reported problems
Stryker Corporation · CANNULATED MODULAR TAP · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540710420), received between Jul 18, 2019 and Jul 1, 2020 — classified as 2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture2
- Detachment of Device or Device Component1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2020Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF AN ES2 CANNULATED MODULAR TAP SHEARED OFF INTRA-OPERATIVELY. THE TIP WAS NOT ABLE TO BE RETRIEVED AND WAS LEFT IN THE PATIENT. SURGERY WAS SUCCESSFULLY COMPLETED WITH A BACK UP INSTRUMENT AND NO DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10221920 ↗MalfunctionJul 18, 2019Fracture; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT WHEN THE SURGEON TAPPED THE PEDICLE IN PREPARATION FOR A SCREW, THE THREAD OF THE TAP PULLED AWAY FROM THE BASE, SURGICAL DELAY OF A FEW SECONDS TO SWITCH OUT THE 5.5MM TAP FOR A 4.5MM. NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8802658 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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