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PRECICE® Plating System LP4.5-MRT4BRecalls & reported problems

Nuvasive Specialized Orthopedics, Inc. · PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, Bump · Class 2 · Implant

3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
3

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517021601), received between Feb 22, 2021 and Oct 18, 2021 — classified as 3 injuries.

3 FDA recall records name this device's identifier, 3 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Oct 29, 2021Open, Classified

    The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.

    Z-0319-2022 · Root cause: Device Design · FDA record ↗

  2. Feb 12, 2021Open, Classified

    Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

    Z-1323-2021 · Root cause: Under Investigation by firm · FDA record ↗

  3. Feb 12, 2021Open, Classified

    Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

    Z-1325-2021 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem3

Patient problems

  • Deformity/ Disfigurement2
  • Wound Dehiscence1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    INFORMATION WAS RECEIVED THAT THE PATIENT DEVELOPED A SLIGHT VALGUS DEFORMITY DURING TREATMENT. THE SURGEON ATTRIBUTES THE DEFORMITY PROGRESSION TO THE PLATE'S PLACEMENT.

    Patient problems: Deformity/ Disfigurement

    MAUDE report 12651914 ↗
  • InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER, IT WAS OBSERVED THAT THERE WAS FORMATION OF A SLIGHT VALGUS DEFORMITY IN THE PROXIMAL TIBIA. THE VALGUS DEFORMITY WAS CORRECTED AND STABILIZED WITH A LOW PROFILE LOCKING PLATE FOR THE DURATION OF CONSOLIDATION.

    Patient problems: Deformity/ Disfigurement

    MAUDE report 11363728 ↗
  • InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    INFORMATION WAS RECEIVED THAT A DEBRIDEMENT PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER, THERE WAS WOUND BREAKDOWN ASSOCIATED WITH IMPLANT PLACEMENT ACROSS THE ANKLE JOINT, AN AREA OF LIMITED SOFT TISSUE COVERAGE. THIS RESULTED IN ADDITIONAL IRRIGATION AND DEBRIDEMENT. FULL LENGTH WAS ACHIEVED AND A REMOVAL PROCEDURE WAS PERFORMED ON (B)(6) 2020.

    Patient problems: Wound Dehiscence

    MAUDE report 11363692 ↗

Other Plate, Fixation, Bone devices

All Plate, Fixation, Bone devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.