LCP 245.071Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982169600), received between Jan 17, 2018 and May 10, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Bent” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, AFTER XRAYS WERE TAKEN THE PLATE WAS FOUND TO BE BROKEN. THIS REPORT INVOLVES ONE (1) 3.5MM LCP RECONSTRUCTION PLATE 7 HOLES/98MM. THIS IS REPORT 1 OF 1 FOR (B)(6).

  Patient problems: Failure of Implant

  MAUDE report 16904519 ↗
• InjuryFeb 13, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT A REVISION SURGERY ON THE RADIUS DUE TO DELAYED HEALING AND NON-UNION. THE PATIENT ORIGINALLY HAD BOTH BONE FOREARM FRACTURED. THE LOCKING COMPRESSION PLATE (LCP) WAS APPLIED TO THE ULNA AND A RECONSTRUCTION PLATE WAS APPLIED TO THE RADIUS IN 2018. THE RECON PLATE WAS OBSERVED TO BE BENT AND FRACTURE MALREDUCED. THE MALFUNCTIONED PLATE WAS REMOVED AND FRACTURE WAS FIXED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT STATUS WAS REPORTEDLY FINE.

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

  MAUDE report 8336022 ↗
• InjuryAug 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS LOOKING TO SEE WHAT METAL WAS IN THE PLATES THAT SHE HAD IMPLANTED APPROXIMATELY THIRTEEN (13) YEARS AGO. SHE STATED SHE RECENTLY HAD SWELLING IN HER ARMS AND WAS UNSURE IF THIS WAS RELATED TO HER AGE OR THE IMPLANTS. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Reaction; Swelling

  MAUDE report 7814297 ↗
• InjuryJan 17, 2018Bent; Bent

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH A 3.5 MM LOCKING COMPRESSION PLATE (LCP) RECONSTRUCTION PLATE AND SEVEN (7) CORTEX SCREWS ON (B)(6) 2017. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 DUE TO NON-UNION AND A BENT PLATE. THE BENT PLATE WAS REMOVED AND REPLACED WITH ANOTHER PLATE. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: CORTEX SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 7). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7201100 ↗

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,