LCP 226.581Recalls & reported problems
Synthes GmbH · 4.5MM BROAD LCP® PLATE 8 HOLES/152MM · Class 2 · Implant
All models of LCP (367)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982159076), received between Mar 17, 2021 and May 9, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Device-Device Incompatibility1
Patient problems
- Impaired Healing1
- No Clinical Signs, Symptoms or Conditions1
- Wound Dehiscence1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT #65: 55-YEAR-OLD FEMALE WAS IMPLANTED WITH LCP BROAD PLATES 4.5/5.0 (226.581) IN TIBIA WITH DPS SCREWS (UNKNOWN QUANTITY) WITH NO ADJUNCTIVE FIXATION. POST-OPERATIVE COMPLICATION: WOUND BREAKDOWN EXPERIENCED 4 WEEKS POST-OP RELATED TO SYNTHES DEVICE. TREATMENT: SURGICAL TREATMENT FOR I&D AND WOUND CLOSURE PERFORMED 4 WEEKS POST-OP. OUTCOME: RECOVERED/RESOLVED. THIS REPORT IS FOR A 4.5MM BROAD LCP® PLATE 8 HOLES/152MM. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Wound Dehiscence
MAUDE report 19279087 ↗InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT #57: 51-YEAR-OLD FEMALE WAS IMPLANTED WITH LCP BROAD PLATES 4.5/5.0 (226.581) IN TIBIA WITH DPS SCREWS (UNKNOWN QUANTITY) WITH NO ADJUNCTIVE FIXATION. POST-OPERATIVE COMPLICATION: I&D AND WOUND CLOSURE EXPERIENCED 4 WEEKS POST-OP RELATED TO SYNTHES PROCEDURE. TREATMENT: SURGICAL TREATMENT FOR I&D AND WOUND CLOSURE PERFORMED 4 WEEKS POST-OP. OUTCOME: RECOVERED/RESOLVED. THIS REPORT IS FOR A 4.5MM BROAD LCP® PLATE 8 HOLES/152MM. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: Impaired Healing
MAUDE report 19279022 ↗MalfunctionMar 17, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, ONE (1) BROAD LOCKING COMPRESSION PLATE HOLE STRIPPED AND THE LOCKING HOLE DID NOT ENGAGE, ONE (1) BROAD LOCKING COMPRESSION PLATE BROKE AFTER EXCESSIVE BENDING, AND THE PINS OF A EIGHT (8) SHANZ SCREW BLUNTED TROCAR POINT HAD A BROKEN TIPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THREE (3) MINUTE SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) 4.5MM BROAD LCP PLATE 8 HOLES/152MM. THIS IS REPORT 2 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11504689 ↗
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- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, 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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