CoLink® 2 P42 ST139Recalls & reported problems
In2Bones USA, LLC · CoLink® 2 MTP Plate NX, Narrow, 6-Hole, Right · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810021862828), received between Jul 13, 2021 and Jul 13, 2021 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Fracture1
Patient problems
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2021Fracture; Fracture
IT WAS REPORTED THAT A PATIENT HAD A BROKEN PLATE AFTER A REVISION SURGERY TO ANOTHER COMPANY'S HARDWARE. THE PLATE WAS RETURNED AND IT WAS CONFIRMED TO BE BROKEN AT THE SCREW HOLE IN THE MIDDLE OF THE PLATE. THE PLATE PERFORMED AS INTENDED DURING THE NORMAL HEALING TIMEFRAME, BUT THERE WAS A NONUNION AFTER 5 MONTHS AND THE PLATED CONTINUED TO BE PLACED UNDER STRESS. NO INFORMATION WAS RECEIVED RELATED TO PATIENT HISTORY OR SUDDEN DEATH. THE MOST LIKELY ROOT CAUSE OF THE PLATE BREAKING IS A NONUNION.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 12159347 ↗
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- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive Specialized Orthopedics, Inc. · Plate, 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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