NA 02.100.116Recalls & reported problems
Synthes GmbH · 3.5MM LOCKING LOW PROFILE RECON PLATE 16 HOLES · Class 2 · Implant
Data updated Oct 18, 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 10886982028518), received between Nov 10, 2021 and Nov 10, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2021Break; Break
IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR REMOVAL OF HARDWARE DUE TO HUMERUS FAILED CONSTRUCT WITH PLATE AND SCREWS BREAKAGE. DEVICES WERE EXPLANTED. PATIENT WAS REVISED WITH A NEW PLATE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: PROXIMAL HUMERAL PLATE (PART# 241.901, LOT# UNKNOWN, QUANTITY 1). UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 7). UNKNOWN LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 6). THIS COMPLAINT INVOLVES (4) DEVICES. THIS REPORT IS FOR (1) 3.5 LCKNG LOW PROFILE RECON PL 16 HOLES. THIS IS REPORT 2 OF 4 FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12786286 ↗
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- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- 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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