LCP 241.921Recalls & reported problems
Synthes GmbH · 3.5MM LCP® PROXIMAL HUMERUS PLATE-LONG 8H SHAFT/196MM · Class 2 · Implant
All models of LCP (367)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982167682), received between Mar 7, 2018 and Mar 7, 2023 — classified as 1 injury, 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2023 DURING AN UNKNOWN PROCEDURE WHEN APPLYING A PROXIMAL HUMERUS PLATE, THE ONE OF THE CRITICAL LOCKING SCREWS PROXIMAL IN THE PLATE WOULD NOT ENGAGE WITH THE LOCKING SCREW. ANOTHER PLATE/SCREW WAS USED WITHOUT FURTHER INCIDENT. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 3.5 LCP PROX HUM PL-LONG 8H SFT/196 THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16499524 ↗InjuryMar 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2017, PATIENT WAS IMPLANTED WITH PROXIMAL HUMERUS PLATE, 3.5 CORTEX SCREWS (QUANTITY OF 4) AND 3.5 LOCKING SCREWS (QUANTITY OF 8). POST-OPERATIVE, PATIENT COMPLAINED OF PAIN. A PHYSICIAN TOLD THE PATIENT THE PLATE WAS TOO LONG SO SHE WANTED IT REMOVED AND WANTED TO KEEP HARDWARE. THE ATTENDING TAKING IT OUT STATED HE FELT LIKE THE PLATE WAS APPROPRIATE FOR HER FRACTURE AND EVERYTHING LOOKED GOOD. THE IMPLANTS WERE EXPLANTED ON (B)(6) 2018. THE BONE WAS HEALED. THERE WAS NO SURGICAL DELAY. THE PATIENT STATUS WAS COMPLETE/OK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 3.5MM LCP® PROXIMAL HUMERUS PLATE-LONG 8H SHAFT/196MM. (B)(4).
Patient problems: No Code Available; Pain
MAUDE report 7320721 ↗
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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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