Pro-X1 XBT110195Recalls & reported problems
X-Bolt Orthopedics Inc. · 195mm x Ø11.0mm, 125° Short Trochanteric Nail · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05397283000472), received between Jun 26, 2025 and Nov 24, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Patient-Device Incompatibility1
Patient problems
- Loss of fracture reduction2
- Joint Impingement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT REQUIRED REMOVAL OF IMPLANT AND REVISION SURGERY TO CONVERT FEMORAL NAIL IMPLANT TO HEMIARTHROPLASTY DUE TO LOSS OF FRACTURE REDUCTION AND JOINT IMPINGEMENT. IMPLANT WAS INTACT WHEN PATIENT PRESENTED FOR THE REVISION SURGERY. PATIENT PAIN LEVELS ARE UNKNOWN. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Joint Impingement; Loss of fracture reduction
MAUDE report 23629326 ↗InjuryJun 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
PHYSICIAN REPORTED THAT PATIENT COMPLICATION WAS FOUND AT FIRST FOLLOW-UP VISIT. POST-OPERATIVE X-RAYS SHOW REDUCTION LOSS WITH ADVISED NEED FOR SURGICAL INTERVENTION/REVISION, HOWEVER, PATIENT ELECTED FOR NO INTERVENTION. PATIENT PAIN LEVELS ARE UNKNOWN. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Loss of fracture reduction
MAUDE report 22341064 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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