XIA 4 5 481321040Recalls & reported problems
Stryker Corporation · TITANIUM PREBENT AND PRECUT ROD WITHOUT HEX · Class 2 · Implant
All models of XIA 4 5 (32)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 07613327001365), received between Apr 4, 2017 and Apr 4, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Difficult to Remove2
- Mechanical Problem2
- Device Slipped1
Patient problems
- Injury2
- No 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.
MalfunctionApr 4, 2017Mechanical Problem; Difficult to Remove; Device Dislodged or Dislocated; Mechanical Problem
IT WAS REPORTED THAT; SCREWS IN AN L5/S1 FUSION PULLED OUT OF THE L5 SCREWS BILATERALLY. UPDATE 3/8/2017: CORRECTION: THE RODS PULLED OUT OF THE L5 SCREWS. THE BLOCKERS WERE STILL ENGAGED IN THE L5 SCREWS AND DIFFICULT TO REMOVE.
Patient problems: Injury; No Information
MAUDE report 6458104 ↗InjuryApr 4, 2017Mechanical Problem; Difficult to Remove; Device Slipped; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated
IT WAS REPORTED THAT; SCREW IN AN L5/S1 FUSION PULLED OUT OF THE L5 SCREWS BILATERALLY. UPDATE (B)(6) 2017: CORRECTION: THE RODS PULLED OUT OF THE L5 SCREWS. THE BLOCKERS WERE STILL ENGAGED IN THE L5 SCREWS AND DIFFICULT TO REMOVE.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 6458099 ↗
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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 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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