MANTIS 48487100Recalls & reported problems
Stryker Corporation · HEX STRAIGHT ROD · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540671721), received between Jan 3, 2020 and Feb 4, 2025 — classified as 1 injury, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 4, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY FIVE YEARS POST-OPERATIVELY TO ADDRESS A FRACTURED XIA ROD.
Patient problems: Insufficient Information
MAUDE report 21309179 ↗MalfunctionJan 3, 2020Fracture; Fracture
IT WAS REPORTED THAT A XIA DEFORMITY REDUCTION LONG ARM MONOXIAL SCREW AND A MANTIS LONG CONSTRUCT HEX STRAIGHT ROD WAS FOUND FRACTURED DURING SCREW AND ROD REMOVAL POST-OPERATIVELY. THIS RECORD REPRESENTS THE ROD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9547806 ↗
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- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.