NA 241.35Recalls & reported problems
Synthes GmbH · ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/61MM · Class 2 · Implant
Data updated Oct 16, 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 10886982166845), received between Aug 24, 2023 and Aug 24, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Migration1
Patient problems
- Insufficient Information1
- Muscular Rigidity1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A ONE-THIRD TUBULAR PLATE FOR AN ANKLE FRACTURE ON AN UNKNOWN DATE. CORTICAL AND CANCELLOUS SCREWS WERE USED FOR FIXATION. HARDWARE WAS REMOVED AT 28 WEEKS POSTOPERATIVELY DUE TO JOINT RIGIDITY AND PAIN. UNION HAD BEEN ACHIEVED AT APPROXIMATELY 12 WEEKS. THIS REPORT INVOLVES ONE ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/61MM. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: Muscular Rigidity; Pain
MAUDE report 17613392 ↗InjuryAug 24, 2023Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT A ONE-THIRD TUBULAR PLATE FOR TREATMENT OF AN ANKLE FRACTURE ON AN UNKNOWN DATE. CORTEX SCREWS WERE USED FOR FIXATION. AT 20 WEEKS POSTOPERATIVELY, HARDWARE WAS REMOVED DUE TO PLATE PROMINENCE. UNION HAD BEEN ACHIEVED AT 12 WEEKS. THIS REPORT INVOLVES ONE ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/61MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 17613171 ↗
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- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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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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