NA 243.13Recalls & reported problems
Synthes GmbH · 2.0MM STRAIGHT PLATE 3 HOLES/17MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982168979), received between May 24, 2019 and May 24, 2019 — classified as 3 injuries.
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 Problem3
Patient problems
- Nonunion/Delayed-union Bone Fracture3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 4 OF 4 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 33 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4) FOR ADDITIONAL DEVICES.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 8641836 ↗InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 3 OF 4 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 32 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4) FOR ADDITIONAL DEVICES.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 8641793 ↗InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 2 OF 4 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 31 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4) FOR ADDITIONAL DEVICES.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 8641718 ↗
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- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive 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-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PRT42Nuvasive 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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