XIA 3 482316535Recalls & reported problems
Stryker Corporation · POLYAXIAL SCREW · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540562227), received between Feb 2, 2017 and Jun 1, 2018 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Loosening of Implant Not Related to Bone-Ingrowth2
- Fracture1
- Material Integrity Problem1
Patient problems
- Injury3
- Failure of Implant1
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 1, 2018Break; Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT ON (B)(6) 2014 PATIENT WAS IMPLANTED FROM T10 TO ILIAC AND 4 RODS WERE DEPLOYED FROM T10 TO L4 AND 2 RODS WERE DEPLOYED AFTER L5. AFTER THE OPERATION, THE 2 RODS WERE BROKEN UNDER L4. ON (B)(6) 2018 A REVISION SURGERY WAS PERFORMED AND THE BROKEN RODS WERE REMOVED AND 4 RODS WERE IMPLANTED. LOOSE S1 SCREWS WERE EXCHANGED WITH NEW 1MM THICK SCREWS.
Patient problems: Injury; No Information
MAUDE report 7560733 ↗InjuryJun 1, 2018Break; Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT ON (B)(6) 2014 PATIENT WAS IMPLANTED FROM T10 TO ILIAC AND 4 RODS WERE DEPLOYED FROM T10 TO L4 AND 2 RODS WERE DEPLOYED AFTER L5. AFTER THE OPERATION, THE 2 RODS WERE BROKEN UNDER L4. ON (B)(6) 2018 A REVISION SURGERY WAS PERFORMED AND THE BROKEN RODS WERE REMOVED AND 4 RODS WERE IMPLANTED. LOOSE S1 SCREWS WERE EXCHANGED WITH NEW 1MM THICK SCREWS.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 7560667 ↗InjuryFeb 2, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT THE SURGERY WITH FOR TH10-L1(PLF). ON (B)(6) 2016, THE PATIENT UNDERWENT THE REVISION SURGERY FOR L2-3(PLIF). AFTER SURGERY, WHEN THE SURGEON CHECKED X-RAY, THE SCREW BROKE. THEREFORE, THE SURGEON PLANNING THE REVISION SURGERY NOW.
Patient problems: Failure of Implant; Injury
MAUDE report 6296255 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.