LCP 223.414Recalls & reported problems
Synthes GmbH · 3.5MM LCP® METAPHYSEAL PLATE 14 HOLES · Class 2 · Implant
Data updated Oct 13, 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 10886982157652), received between Jan 5, 2023 and Jan 6, 2023 — classified as 2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Nonunion/Delayed-union Bone Fracture1
- Physical Asymmetry1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE REPORT FROM THE NETHERLANDS REPORTS AN EVENT AS FOLLOWS: SUBJECT: (B)(4). AE2: POSTOPERATIVE ADVERSE EVENT: " NONUNION ". IS THE AE RELATED TO THE TIBIAL FRACTURE AND/OR TREATMENT OF TIBIAL FRACTURE? "YES". IS THE AE RELATED TO THE DEVICE? "YES". DPS IMPLANT WAS USED. THIS REPORT IS FOR A 3.5MM LCP® METAPHYSEAL PLATE 14 HOLES. THIS IS REPORT 1 OF 12 FOR (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 16116225 ↗InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE REPORT FROM THE NETHERLANDS REPORTS AN EVENT AS FOLLOWS: SUBJECT (B)(6). POSTOPERATIVE ADVERSE EVENT: " OTHER AE RELATED TO THE PROCEDURE OR IMPLANT: VALGUS COMPARED TO CONTRALATERAL; COULD INFLUENCE STABILITY AND FUNCTION. " IS THE AE RELATED TO THE TIBIAL FRACTURE AND/OR TREATMENT OF TIBIAL FRACTURE? "YES." IS THE AE RELATED TO THE DEVICE? "YES." DPS IMPLANT WAS USED. THIS REPORT IS FOR A 3.5MM LCP® METAPHYSEAL PLATE 14 HOLES. THIS IS REPORT 1 OF 12 FOR (B)(4).
Patient problems: Physical Asymmetry
MAUDE report 16106461 ↗
Other APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE devices
- LOCK SCREW SQUARE DRIVE 131827118Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE1 recall0 reports
- LOCK SCREW SQUARE DRIVE 131827120Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE1 recall0 reports
- IJS IJS-E Base Plate AssemblySkeletal Dynamics L.L.C. · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE28 reports
- NA 390.008Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE21 reports
- NA 294.56Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE8 reports
- NA 390.003Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE8 reports
- NA 394.85Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE8 reports
- NA 390.051Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE6 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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