LCP 239.957Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982163530), received between Sep 7, 2018 and Aug 1, 2023 — 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2023Device-Device Incompatibility; No Apparent Adverse Event; Device-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6), 2023, THE DEPTH GAUGE WAS BENT AT THE TIP AND NEED TO BE REPLACED. ADDITIONALLY WHEN VA LOCKING SCREWS WERE BEING FINAL TORQUED, THE SCREWS SEEMED TO BE STRIPPING OUT IN THE LOCKING MECHANISM. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE (1) 3.5MM LCP® MEDIAL PROXIMAL TIBIA PLATE 6H/LEFT 119MM. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17432550 ↗
• InjurySep 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF HARDWARE FROM PROXIMAL TIBIA DUE TO INFECTION. ORIGINALLY, THE PATIENT HAD IMPLANTATION IN 2013. ALL HARDWARE REMOVED INTACT SIMULTANEOUSLY WITH INCISION AND DRAINAGE (I&D). IT WAS REPORTED THAT FRACTURED WAS HEALED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY REPORTED. THIS IS REPORT 1 FOR 10 (B)(4). THE RELATED IS (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 9130007 ↗
• InjurySep 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2018, A 3.5MM LOCKING COMPRESSION PLATE (LCP) MEDIUM PROXIMAL TIBIAL LEFT 6 HOLES WAS NOT INCLUDED IN THE COMPANY'S VOUCHER. A 4.5MM LCP PROXIMAL TIBIA PLATE 6 HOLES WAS CHOSEN TO PROCEED WITH THE SURGERY FOLLOWING THE INFORMATION ON THE PLATE. THE SURGEON WAS ALSO VERY ANNOYED THAT THE SURGERY WAS DELAYED DUE TO THE DELAY IN DELIVERY OF THE MATERIAL. IT WAS A BIG SURGERY, EXTREMELY DIFFICULT BUT IT TURNED OUT ALL RIGHT. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM LCP® MEDIAL PROXIMAL TIBIA PLATE 6H/LEFT 119MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7857259 ↗