CurvaFix® IM Implant 7.5 mm x 120 mmRecalls & reported problems
Curvafix, Inc. · The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel. · 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 10855068008669), received between May 1, 2025 and Jul 22, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Lack of Effect” (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
- Lack of Effect1
- Malposition of Device1
Patient problems
- Loss of fracture reduction1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2025Lack of Effect; Lack of Effect
INITIAL SURGERY WAS PERFORMED ON (B)(6) 2025 FOR POSTERIOR AND ANTERIOR RING FIXATION USING CURVAFIX IN S1 AND ANTERIOR COLUMN (PARASYMPHASEAL); HIGH-ENERGY FRACTURE. 12 DAYS POST-OP, THE PATIENT REPORTED A "POP" AN ACUTE INCREASE IN PAIN. FOLLOW-UP FOUND THAT CURVAFIX IMPLANT (ANTERIOR COLUMN) BACKED OUT, RESULTING IN LOSS OF REDUCTION. REVISION SURGERY WAS DISCUSSED, WHICH THE PATIENT DECLINED. AT THIS TIME, THE PATIENT IS REQUESTING NO ADDITIONAL SURGICAL INTERVENTION.
Patient problems: Loss of fracture reduction
MAUDE report 22571272 ↗InjuryMay 1, 2025Malposition of Device; Malposition of Device
A CURVAFIX DEVICE WAS MALPOSITIONED DURING INITIAL IMPLANTATION. A SECONDARY SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE MALPOSITIONED IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21944539 ↗
Other Screw, Fixation, Bone devices
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- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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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