CurvaFix® IM Implant 7.5 mm x 130 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 10855068008676), received between Aug 8, 2024 and Jun 6, 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
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Ambulation or Postural Difficulties1
- Arthralgia1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT TREATED FOR AN ANTERIOR RING PARASYMPHASEAL INJURY WAS TREATED WITH TWO CURVAFIX IMPLANTS IN THE S1 AND THE AC ON (B)(6) 2025. AN INTERVIEW WITH THE IMPLANT SURGEON WAS HELD ON (B)(6) 2025 WHEN THE SURGEON COMMENTED THAT THE PATIENT REQUIRED A BLOOD TRANSFUSION OWING TO BLOOD LOSS DURING DEVICE IMPLANTATION SURGERY ON (B)(6) 2025.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22160991 ↗InjuryAug 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
18 MONTHS AFTER IMPLANTATION, A CURVAFIX IM IMPLANT WAS IDENTIFIED AS HAVING BEEN BROKEN AFTER PATIENT IMAGING. THE PATIENT HAD REPORTED PAIN AND DEVELOPED A LIMP. AS OF THE DATE OF THIS REPORT, THE SUBJECT IMPLANT REMAINS IMPLANTED IN THE PATIENT. THE SURGEON HAS INDICATED A REVISION SURGERY IS PLANNED BUT NOT YET SCHEDULED.
Patient problems: Ambulation or Postural Difficulties; Arthralgia
MAUDE report 19943110 ↗
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- 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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