LCP 02.124.220Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982042651), received between May 2, 2019 and Sep 15, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION SURGERY DUE TO NONUNION AND A BENT PLATE. THE REVISION SURGERY WAS SCHEDULED FOR LATER THAT DAY. PATIENT HAD A NONUNION OF A TIBIA PLATEAU FRACTURE. ORIGINAL FRACTURE WAS OF THE PROXIMAL TIBIA TREATED WITH A 3.5MM LCP PROXIMAL TIBIA PLATE AND ASSOCIATED 3.5MM LOCKING SCREWS. THE PATIENT REQUIRED A REVISION SURGERY DUE TO PAIN AND BOWING OF THE TIBIA. THE PLATE AND ALL SCREWS WERE REMOVED. THE FRACTURE WAS PROPERLY REDUCED, AND A TIBIA NAIL X WAS IMPLANTED. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. PATIENT EXPERIENCED PAIN AND DEFORMITY. THIS COMPLAINT INVOLVES TEN(10) DEVICES. THIS REPORT IS FOR (1) 3.5 LCP PROX TIB PL LOW BEND 14 H/206/RT THIS REPORT IS 1 OF 10 FOR (B)(4). .

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12477809 ↗
• InjuryMay 2, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF HARDWARE DUE TO MALUNION AND (1) LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIA BROKE. THERE WAS NO SURGICAL DELAY REPORTED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 75MM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 60MM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 2); LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 70MM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 2); LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 26MM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 24MM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 30MM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); CANCELLOUS BONE SCREW FULLY THREADED 26MM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); CANCELLOUS BONE SCREW FULLY THREADED 30MM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1)/ THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8574744 ↗