LCP 241.444Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982167071), received between May 23, 2018 and Oct 5, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON REMOVED A BROKEN 3.5MM LOCKING COMPRESSION PLATE ANTEROLATERAL DISTAL TIBIA PLATE 9 HOLES/RIGHT AND FOUR (4) SCREWS. THE SURGEON LEFT THE PART OF THE PLATE AND THREE (3) SCREWS STILL IN PATIENT. THIS WAS A NON UNION CASE SO THE SURGEON USED A SMITH AND NEPHEW NAIL TO FIX THE PATIENT. THE FOUR (4) SCREWS WERE NOT BROKEN AND REMOVED SUCCESSFULLY. THE REASON THAT THE PLATE AND THREE (3) SCREWS STILL IN THE PATIENT WAS AS MENTIONED, THE PATIENT HAD A NON UNION SO THE PLATE AND THREE (3) SCREWS HELPED TO STABILIZE THE ANKLE JOINT AND SURGEON IMPLANTED A SMITH AND NEPHEW TIBIA NAIL ABOVE THE PLATE AND SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. SURGICAL DELAY WAS UNKNOWN. THERE IS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE (TM) RECESS 28MM (PART #: 212.110, LOT #: UNKNOWN, QUANTITY: 2). 3.5MM CORTEX SCREW SELF-TAPPING 28MM (PART #: 204.828, LOT #: UNKNOWN, QUANTITY: 2). UNKNOWN SCREW: TRAUMA (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) 3.5MM LCP® ANTEROLATERAL DISTAL TIBIA PL 9 HOLES/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10629627 ↗
• InjuryNov 5, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING PLATING OF A PILON FRACTURE, THE SURGEON USED 3.5MM LOCKING COMPRESSION PLATE (LCP) ANTEROLATERAL DISTAL TIBIA PLATE 9 HOLES RIGHT. THE PLATE ACCEPTS 3.5 MM LOCKING AND CORTICAL SCREWS PROXIMALLY AND 2.7 MM LOCKING DISTALLY. THERE WERE NO ISSUES WITH ANY OF THE 3.5MM SCREWS PROXIMALLY, BUT NONE OF THE 2.7MM LOCKING SCREWS HE DRILLED AND INSERTED DISTALLY ACTUALLY LOCKED INTO THE PLATE, THEY JUST SPUN. THE SURGEON DRILLED AND ATTEMPTED TO INSERT FOUR (4) OR FIVE (5) 2.7MM LOCKING SCREWS DISTALLY, ALL OF WHICH FAILED, BEFORE RESORTING TO USING 2.7MM CORTICAL SCREWS INSTEAD. FOUR (4) OF THE 2.7MM LOCKING SCREW DID NOT LOCK IN THE DISTAL HOLES OF THE PLATE. THE 3.5MM LOCKING SCREWS DID LOCK IN THE PROXIMAL PART OF THE PLATE. HE USED THE APPROPRIATE LOCKING DRILL GUIDE, DRILL, AND SCREWS. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING DRILL GUIDE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN 2.0 DRILL BIT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR 1 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9279688 ↗
• InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE ON UNKNOWN DATE IN 2006. PATIENT WAS IMPLANTED WITH A 3.5MM LOCKING COMPRESSION PLATE (LCP) METAPHYSEAL PLATE, 3.5MM LCP MEDIAL DISTAL TIBIA PLATE, 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATE, FIFTEEN (15) 3.5MM LOCKING SCREWS, AND FIVE (5) 3.5MM CORTEX SCREWS. ON UNKNOWN DATE PATIENT DEVELOPED AN INFECTION OF THE ANKLE. X-RAY TAKEN ON UNKNOWN DATE REVEALED ONE OF THE SCREWS WAS ALSO BROKEN. IT IS UNKNOWN IF THE BROKEN SCREW WAS A LOCKING OR CORTEX SCREW. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED THE THREE (3) PLATES AND NINETEEN (19) SCREWS EASILY. THE BROKEN SCREW WAS TREPHINED IN ORDER TO ACCOMMODATE REMOVAL. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT STATUS REPORTED AS OKAY. THIS REPORT IS FOR ONE (1) 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATE THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7539026 ↗

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,