CurvaFix® IM Implant 9.5 MM x 150 MM, Self TappingRecalls & 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
- 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 10855068008041), received between Oct 11, 2023 and Oct 11, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- Implant Pain1
- Inadequate Pain Relief1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 11, 2023Fracture; Fracture
IT WAS REPORTED THAT A PATIENT, TREATED 9-10 MONTHS PREVIOUSLY FOR A SACRAL NON-UNION, PRESENTED WITH POSTERIOR SACRAL PAIN. X-RAY IMAGING FOUND THAT THE SUBJECT IMPLANT WAS BROKEN, ALTHOUGH STILL IN ITS ORIGINAL LOCATION AXIALLY. OTHER IMPLANTED HARDWARE (STRAIGHT SCREW) WAS ALSO FOUND BROKEN, WITH THE PROXIMAL PIECE BACKED OUT SEVERAL CENTIMETERS. HARDWARE EXTRACTION WAS PERFORMED USING TYPICAL ORTHOPEDIC INSTRUMENTS, BONY OVERGROWTH WAS REMOVED FROM OVER THE HEAD, AND THE IMPLANT WAS FULLY REMOVED WITH NO PIECES LEFT BEHIND.
Patient problems: Implant Pain; Inadequate Pain Relief
MAUDE report 17916304 ↗
Other Rod, Fixation, Intramedullary And Accessories devices
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- NA 03.037.026Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES225 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls2 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-045Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE Intramedullary Limb Lengthening System LSB5-040Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 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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