NA 241.33Recalls & reported problems
Synthes GmbH · ONE-THIRD TUBULAR PLATE WITH COLLAR 3 HOLES/37MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982166807), received between Aug 24, 2023 and Aug 24, 2023 — classified as 1 injury.
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
Patient problems
- Muscular Rigidity1
- Pain1
Recent adverse event reports
The 1 most recent of 1 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 UNDERWENT SURGERY TO IMPLANT A ONE-THIRD TUBULAR PLATE FOR ANKLE FRACTURE FIXATION ON AN UNKNOWN DATE. CORTICAL AND CANCELLOUS SCREWS WERE USED FOR FIXATION, AS WELL AS AN ADDITIONAL VA LCP T FUSION PLATE. FIFTEEN WEEKS POSTOPERATIVELY, THE PATIENT EXPERIENCED JOINT RIGIDITY AND PAIN. HARDWARE WAS REMOVED. UNION HAD BEEN ACHIEVED AT APPROXIMATELY 12 WEEKS. THIS REPORT INVOLVES ONE ONE-THIRD TUBULAR PLATE WITH COLLAR 3 HOLES/37MM. THIS IS REPORT 1 OF 4 FOR (B)(4).
Patient problems: Muscular Rigidity; Pain
MAUDE report 17612920 ↗
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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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