LCP 226.591Recalls & reported problems
Synthes GmbH · 4.5MM BROAD LCP® PLATE 9 HOLES/170MM · 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 10886982159090), received between Mar 22, 2018 and Dec 24, 2020 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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
- Adverse Event Without Identified Device or Use Problem2
- Material Twisted/Bent1
Patient problems
- No Code Available2
- No Clinical Signs, Symptoms or Conditions1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 24, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2020, 3 PLATES WERE STRIPPED, AND LOCKING SCREWS DID NOT LOCK INTO THE PLATES. THE PLATES IN QUESTION WERE 4.5MM BROAD LCP® PLATE 9 HOLES/170MM, 4.5MM BROAD LCP® PLATE 10 HOLES/188MM, AND 4.5MM BROAD LCP® PLATE 11 HOLES/206MM. THE PROCEDURE WAS COMPLETED USING ANOTHER SET OF IMPLANTS. THERE WAS A SURGICAL DELAY OF 5 MINUTES. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR 1 4.5MM BROAD LCP® PLATE 9 HOLES/170MM. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11072250 ↗InjuryFeb 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF A NARROW LARGE FRAG PLATE WITH 8 SCREWS IN THE RIGHT HUMERAL SHAFT AND 1/3 TUBULAR PLATE WITH 5 SCREWS FROM THE ANTERIOR OF THE HUMERAL SHAFT TO TREAT NON-UNION. THE PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) 4.5 MM BROAD LCP® PLATE 9 HOLES/ 170 MM. (B)(4).
Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture
MAUDE report 9678182 ↗InjuryMar 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD TO UNDERGO A REVISION SURGERY ON (B)(6) 2018 FOR REMOVAL OF 4.5MM BROAD LOCKING COMPRESSION PLATE (LCP) 9 HOLES/170MM AND UNKNOWN SCREWS IMPLANTED ON (B)(6) 2013. THE REVISION SURGERY WAS CARRIED OUT AS THE PATIENT HAD THE COMPLAINT OF SENSITIVITY TO THE PLATE ON THE HUMERUS. DURING THE REVISION SURGERY ONE 4.5MM BROAD LCP PLATE 9 HOLES/170MM AND TEN UNKNOWN SCREWS WERE REMOVED INTACT. NOTHING WAS IMPLANTED AFTER REMOVAL OF PLATE AND SCREWS. SUCCESSFUL UNION OF FRACTURE HAD OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THE PATIENT WAS STABLE AFTER THE SURGERY. THIS REPORT IS FOR ONE (1) 4.5MM BROAD LCP® PLATE 9 HOLES/170MM. (B)(4).
Patient problems: No Code Available
MAUDE report 7361521 ↗
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- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- 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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