LCP 224.661Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982158628), received between Oct 23, 2017 and Oct 23, 2017 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2017Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 DUE TO BROKEN PLATE AND TO TREAT TIBIA FRACTURE. INITIALLY THE PATIENT WAS IMPLANTED WITH ONE (1) PLATE AND 12 (TWELVE) SCREWS. THE PLATE BROKE INTERNALLY AND PATIENT PRESENTED WITH PAIN. THE FRACTURE DID NOT HEAL AS EXPECTED (NON-UNION). DUE TO THIS REASON, REVISION SURGERY WAS PERFORMED. ALL IMPLANTS (1 PLATE AND 12 SCREWS) REMOVED WITHOUT ANY DIFFICULTY. POST-OPERATIVE X-RAYS CONFIRMED NO FRAGMENTS WERE RETAINED. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT WAS REVISED TO NEW SYNTHES PLATE AND ALSO COMPETITOR¿S DEVICE (RESTORATION HIP, STRYKER). PATIENT IS NOW REPORTED TO BE IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: CORTEX SCREW (PART #: 214.836, QTY: 2), CORTEX SCREWS (PART #: 214.850, QTY: 2), CORTEX SCREWS (PART #: 214.838, QTY: 6), CORTEX SCREW (PART #: 214.840, QTY: 1), CORTEX SCREW (PART #: 214.834, QTY: 1) THIS REPORT IS FOR ONE(1) 4.5 MM NARROW LCP PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 6969799 ↗