Sure-Lok Extended Tab Pedicle Screw System HXI-48-0003Recalls & reported problems
Precision Spine, Inc. · K-Wire, NI Trocar/Blunt Tip · Class 1
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 00840019922654), received between Aug 15, 2023 and Aug 15, 2023 — 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
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2023Break; Break
IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2023, UTILIZING THE REFORM TI MIS CT PEDICLE SCREW SYSTEM. WHILE THE SURGEON WAS TRYING TO REMOVE THE K-WIRE, NI BLUNT/THREADED (HXI-48-0003) FROM THE SECOND SCREW AT L4, IT BROKE CLEAN AT THE "KNURLED" PART FROM THE SMOOTH PART. NO ATTEMPT WAS MADE TO TRY TO RETRIEVE THE BROKEN PIECE, WHICH REMAINS IN THE PATIENT'S PEDICLE. MORE CARE WAS TAKEN WITH THE FINAL POSITIONING OF THE SCREW TO ENSURE THE BROKEN TIP DID NOT ADVANCE ANY MORE WITH THE SCREW BEING ADVANCED. THE SURGERY AS COMPLETED WITH OPTIMAL OUTCOME WITHOUT DELAY. THE REMAINDER OF THE K-WIRE IS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17552763 ↗
Other Passer, Wire, Orthopedic devices
- Phantom Hindfoot TTC/TC Nail System P31-955-1800-SParagon 28, Inc. · PASSER, WIRE, ORTHOPEDIC1 recall4 reports
- Guide Wire Kit, 5.5/6.5/7.3 Cannulated Screws GWK 300Flower Orthopedics Corporation · Passer, Wire, Orthopedic1 recall1 report
- Guide Wire Kit, 2.0/2.4 Cannulated Screws GWK 100Flower Orthopedics Corporation · Passer, Wire, Orthopedic2 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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