Nanoplasty System SD29Recalls & reported problems
Treace Medical Concepts, Inc. · Bicortical Screw Pack · Class 2 · Implant
All models of Nanoplasty System (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810111222525), received between Mar 24, 2026 and Sep 18, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Bone Fracture(s)1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Loosening of Implant Not Related to Bone-Ingrowth
It was reported that after an initial bunion surgery on (b)(6) 2026, a bi-cortical screw was removed on (b)(6) 2026 as it had backed out. Review of radiographic images indicated a post-operative fracture of the medial cortex. No other patient outcomes were reported as a result of this event.
Patient problems: Bone Fracture(s)
MAUDE report 50819118 ↗InjuryMar 25, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2026, ALL HARDWARE WAS REMOVED ON (B)(6) 2026 DUE TO THE BICORTICAL SCREW BACKING OUT AND CALLUS FORMATION AT OSTEOTOMY. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689486 ↗InjuryMar 24, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2026, ALL HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2026 DUE TO THE BICORTICAL SCREW BACKING OUT. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24682338 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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