Xia 3 System - Serrato 48260245Recalls & reported problems
Stryker Corporation · Navigated Tap · Class 2
All models of Xia 3 System - Serrato (36)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327353051), received between Sep 14, 2018 and Sep 14, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
- No Apparent Adverse Event1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2018Break; No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT DURING AN L4/5 PLIF, UPON INSERTION OF PEDICLE SCREW INTO L4 VERTEBRAL BODY, THE PEDICLE ROOT BROKE. IT WAS ALSO REPORTED THAT THE PEDICLE WAS DEFORMED DUE TO DEGENERATIVE SCOLIOSIS. THERE WAS NO REPORTED ISSUE WITH THE DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7879027 ↗
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- REAL INTELLIGENCE ROB10013Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall528 reports
- VELYS 4515-70-105Depuy (Ireland) · Orthopedic stereotaxic instrument578 reports
- VELYS 4515-70-106Depuy (Ireland) · Orthopedic stereotaxic instrument564 reports
- NA 209999Mako Surgical Corp. · Orthopedic stereotaxic instrument522 reports
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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