LCP 447.346Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982223814), received between Feb 5, 2018 and Feb 5, 2018 — classified as 1 injury.

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

4 other recalls cover devices cleared under the same FDA submission (K063049); 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 18, 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.

• InjuryFeb 5, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WHO WAS IMPLANTED WITH A 2.0 MM TITANIUM LOCKING COMPRESSION PLATE (6 HOLES) AND FOUR LOCKING SCREWS ON (B)(6) 2017, WAS REVISED ON (B)(6) 2018, AFTER THE PLATE WAS FOUND TO BE BROKEN. THE PREVIOUSLY IMPLANTED DEVICES WERE REMOVED AND NEW HARDWARE WAS PLACED. CONCOMITANT DEVICES REPORTED: 2.0 MM TITANIUM CORTEX SCREW, SELF TAPPING W/STARDRIVE RECESS 10 MM (PART 401.360, LOT NUMBER UNKNOWN, QUANTITY 3), 2.0 MM TITANIUM CORTEX SCREW, SELF TAPPING W/STARDRIVE RECESS 11 MM (PART 401.361, LOT NUMBER UNKNOWN, QUANTITY 1), 2.0 MM TITANIUM CORTEX SCREW, SELF TAPPING W/STARDRIVE RECESS 12 MM (PART 401.362, LOT NUMBER UNKNOWN, QUANTITY 1), 2.0 MM TITANIUM CORTEX SCREW, SELF TAPPING W/STARDRIVE RECESS 14 MM (PART 401.364, LOT NUMBER UNKNOWN, QUANTITY 1), THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7240943 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063049. One submission often covers many models, so check the product and lot details in each record.

• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-0167-2016 · Oct 6, 2015 · Terminated
  2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantati
• Z-0380-2014 · Jul 31, 2013 · Terminated
  2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragmen