XIA 3 48237008Recalls & reported problems
Stryker Corporation · UNIVERSAL TIGHTENER · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327265330), received between Jun 27, 2016 and Jun 6, 2018 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
- Break3
- Material Integrity Problem2
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 6, 2018Break; Fracture; Detachment of Device or Device Component; Fracture
IT WAS REPORTED THAT THE UNIVERSAL TIGHTENER HEX BROKE OFF. AN EXTRA TIGHTENER WAS AVAILABLE. NO ADVERSE CONSEQUENCES T THE PATIENT IS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7572703 ↗MalfunctionMar 7, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT; DR WAS TIGHTENING BLOCKER TO ROD VIA TULIP OF SCREW WHEN THE TIP OF THE BLOCKER INSERTER 'GAVE WAY'. BROKEN TIP OF INSERTER WAS RETRIEVED, BUT NOT KEPT UNFORTUNATELY - THROWN AWAY ON ACCIDENT. THE INSERTER WAS USED 1000'S OF TIMES SUCCESSFULLY. CASE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY OR IMPACT TO PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6384169 ↗MalfunctionJan 13, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT A UNIVERSAL TIGHTENER WAS BROKEN AT SCOLIOSIS CORRECTION LEVEL TO ROD DURING THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE SPARE DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6251699 ↗MalfunctionJun 27, 2016Fracture
IT WAS REPORTED THAT THE DEVICE FRACTURED DURING A PROCEDURE. NO DELAY AND NO ADVERSE CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5753069 ↗
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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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