LC-DCP 223.56Recalls & reported problems
Synthes GmbH · 3.5MM LC-DCP® PLATE 6 HOLES/77MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982157904), received between Jan 23, 2018 and Jun 11, 2024 — classified as 4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- Bone Fracture(s)1
- No Code Available1
- Nonunion/Delayed-union Bone Fracture1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON MAY 15, 2024 THE PATIENT HAD A HARDWARE REMOVAL DUE TO BROKEN ULNA ABOVE IMPLANT. PATIENT AND SURGICAL STATUS UNKNOWN. ORIGINAL IMPLANT DATE NOT KNOWN. THIS REPORT IS FOR ONE 3.5MM LC-DCP PLATE 6 HOLES/77MM. THIS IS REPORT 2 OF 10 FOR (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 19511518 ↗InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2024, DUE TO ULNA NON-UNION. HARDWARE WAS REMOVED. THIS REPORT IS FOR A 3.5MM LC-DCP PLATE 6 HOLES/77MM. THIS IS REPORT 1 OF 7 FOR (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 18981896 ↗InjuryApr 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HEALED AND CONTACTED THE HOSPITAL TO HAVE THE HARDWARE REMOVED. ON (B)(6) 2018, A 3.5MM LC-DCP PLATE AND 6 CORTICAL SCREWS WERE REMOVED SUCCESSFULLY. REASON FOR REMOVAL OF HARDWARE WAS DUE TO THE PATIENT PRESENTING WITH A SLIGHT PROMINENCE OF THE IMPLANTS. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FRAGMENTS WERE GENERATED DURING THE PROCEDURE. THE PATIENT IS REPORTED IN STABLE CONDITION. THIS REPORT IS FOR TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 7450611 ↗InjuryJan 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A RIGHT ELBOW HARDWARE REMOVAL WAS PERFORMED ON (B)(6) 2018 DUE TO PATIENT COMPLAINTS OF PAIN. THE ORIGINAL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE IN 2006, AND WAS REVISED IN 2014. REMOVED HARDWARE INCLUDED TWO INTACT PLATES AND A TOTAL OF TWELVE INTACT CORTICAL SCREWS (A COMBINATION OF 3.5MM AND 2.7MM). ONE 3.5MM CORTICAL SCREW HEAD BROKE OFF DURING THE REMOVAL. THE BROKEN SCREW HEAD AND THE EMBEDDED SHAFT WAS RETRIEVED. THERE WAS A SURGICAL DELAY OF FIVE MINUTES TO RETRIEVE THE SCREW SHAFT. NO ADDITIONAL X-RAYS OR OTHER MEDICAL INTERVENTION REQUIRED. NO SIGNS OF INFECTION. THE AREA WAS FULLY HEALED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THE COMPLAINT OF SCREW BROKEN INTRA-OP IS CAPTURED IN (B)(4). (B)(4).
Patient problems: Pain
MAUDE report 7212061 ↗
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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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