LCP 241.051Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982165596), received between Dec 11, 2019 and Apr 17, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K000684); they may or may not involve this specific model.

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.

• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AROUND (B)(6) 2020 THE PATIENT FELL FROM A SCAFFOLDING AND INJURED HIS RIGHT KNEE. THE CT SCAN REVEALED A COMMINUTED BICONDYLAR TIBIAL PLATEAU FRACTURE. AROUND (B)(6) 2020 THE PATIENT UNDERWENT RIGHT TIBIAL ORIF WITH MEDIAL POSTEROMEDIAL PLATING, MEDIAL AND LATERAL MENISCAL REPAIR AND A PROPHYLACTIC 4 COMPARTMENT FASCIOTOMY. THE SURGEON IMPLANTED A PROXIMAL ANTEROLATERAL SYNTHES TIBIAL PLATEAU LOCKING PLATE AND ONE 3.5 POSTEROMEDIAL TIBIAL T PLATE WITH ASSOCIATED SCREWS. THE SURGEON ALSO UTILIZED A SINGLE-USE DRILL BIT. FOLLOWING THE SURGERY OF (B)(6) 2020 THE PATIENT PERFORMED REHABILITATION AND THERAPY AS RECOMMENDED BY HIS MEDICAL PROVIDERS. HOWEVER, HE CONTINUED TO EXPERIENCE PAIN, DISCOMFORT, AND FUNCTIONAL LIMITATIONS IN HIS RIGHT KNEE. ALSO HE EXPERIENCED PROBLEMS WITH WOUND HEALING, INCLUDING INCREASED PAIN, SWELLING, AND DRAINAGE FROM THE INCISION SITE. AROUND (B)(6) 2020 THE PATIENT DIAGNOSED WITH SEPTIC ARTHRITIS. IT WAS DETERMINED THAT THE PATIENT WOULD UNDERGO ADDITIONAL SURGERY FOR HIS WOUND COMPLICATIONS, INCLUDING ARTHROSCOPIC IRRIGATION AND DEBRIDEMENT OF HIS MEDIAL AND LATERAL INCISIONS ALONG WITH THE REMOVAL OF ALL HIS HARDWARE AND THE INSTAL

  Patient problems: Discomfort; Impaired Healing; Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16753382 ↗
• MalfunctionDec 30, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A PROXIMAL RADIUS, THE SURGEON HAD TO CUT THE LOCKING COMPRESSION PLATE (LCP) T- PLATE TO FIT THE PROXIMAL RADIUS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR (1) 3.5MM LCP T-PLATE 3H HEAD/ 5H SHAFT/74MM-OBLIQUE RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119089 ↗
• MalfunctionDec 11, 2019Defective Device; Defective Device

  ISSUE WAS DISCOVERED WHEN CLINICAL WAS BUILDING THE SET.

  Patient problems: No Patient Involvement

  MAUDE report 9453430 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,