LCP 02.104.008Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982029027), received between Dec 22, 2017 and May 13, 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 16, 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.

• InjuryMay 13, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION SURGERY DUE TO PATIENTS HUMERUS HAD A NONUNION. REMOVAL OF THE PLATE AND SCREWS WAS CONDUCTED. SURGEON THEN INSERTED A BONE GRAFT FROM THE PATIENTS TIBIA AND APPLIED A LARGE FRAGMENT PLATE. THREE OF THE CORTEX SCREWS WERE BROKEN AT THE HEAD-SHAFT JUNCTION. ADDITIONAL X-RAYS FOR THE REMOVAL OF BROKEN SCREW SHAFTS. THERE WAS A SURGICAL DELAY OF APPROXIMATELY 15 MINUTES TO SURGICAL TIME. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT WAS REVISED WITH A NEW DEVICE. CONCOMITANT DEVICES REPORTED: UNKNOWN 3.5MM CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 3). THIS COMPLAINT INVOLVES 5 DEVICES. THIS REPORT IS FOR (1) 3.5 LCP X-ARTC DSTL HUM PL 8H/RT 194 LG. THIS REPORT IS 1 OF 5 (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11822319 ↗
• InjuryDec 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) TO REPAIR A DISTAL HUMERUS NONUNION ON (B)(6) 2017. ORIGINALLY, ON AN UNKNOWN DATE SIX MONTHS PRIOR, THE FRACTURE WAS TREATED NON-SURGICALLY WITH A SLING. SUBSEQUENTLY, A NONUNION WAS IDENTIFIED AND DISUSE OSTEOPENIA RELATED TO THE SLING WAS DIAGNOSED. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM ON (B)(6) 2017. THE FRACTURE WAS REDUCED AND AN EIGHT-HOLE PLATE, SCREWS AND BONE GRAFT WERE IMPLANTED DURING AN UNEVENTFUL SURGERY. POSTOPERATIVE X-RAYS THAT SAME DAY SHOWED THAT THE PLATE WAS TOO SHORT, AND THE SURGEON DECIDED TO RETURN THE PATIENT TO THE OPERATING ROOM FOR A HARDWARE REMOVAL AND REVISION ON (B)(6) 2017. THE SURGEON EXPLANTED AND REPLACED THE EIGHT-HOLE PLATE AND PROXIMAL SCREWS WITHOUT INCIDENT. HE RE-USED THE DISTAL SCREWS. THE REVISION CONSTRUCT INCLUDED: ONE 12-HOLE PLATE, ¿90/90¿ PLATED WITH THE 12-HOLE PLATE AND SCREWS AND BONE GRAFT. THERE WERE NO REPORTED SURGICAL DELAYS, NO FRAGMENTS INVOLVED AND NO ADDITIONAL X-RAYS OR ADDITIONAL MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES: LOCKING SCREW (PART

  Patient problems: No Code Available

  MAUDE report 7142935 ↗