LCP 02.112.527Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982034656), received between Apr 21, 2020 and Aug 10, 2021 — classified as 2 injuries, 1 malfunction.

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

• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL MEDIAL DISTAL TIBIA PLATE DUE TO NONUNION AND SKIN BREAKDOWN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FOURTEEN (14) DEVICES. THIS REPORT IS FOR (1) 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/12H/LEFT/213MM. THIS REPORT IS 1 OF 14 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Tissue Injury

  MAUDE report 12303554 ↗
• MalfunctionOct 5, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) LT DISTAL TIBIA FRACTURE THE SURGEON REMARKED 3.5 LOCKING SCREW 42MM AND 3.5 LOCKING SCREW 44MM WOULD NOT LOCK INTO MEDIAL DISTAL TIBIA PLATE. THE SURGEON LEFT ALL THREE IMPLANTS IN THE PATIENT. THERE WAS A SURGICAL DELAY OF TEN MINUTES. THE PATIENT OUTCOME WAS GOOD. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/12H/LEFT/213MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10627649 ↗
• InjuryApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT CAME TO SURGERY FOR REMOVAL OF EXPOSED HARDWARE, A TAKEDOWN OF NONUNION, AND APPLICATION OF MAX FRAME RING FIXATOR. THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SEVERAL MONTHS BACK. THE FRACTURE HAS GONE ON TO NONUNION AND THE SOFT TISSUE OVER THE PLATE DISTALLY HAS OPENED WITH THE HARDWARE EXPOSED TO THE AIR. ALL HARDWARE WAS INTACT AND REMOVED EASILY. THE NONUNION WAS DEBRIDED AND BONE GRAFTED. THE OPEN AREA DISTALLY WAS DEBRIDED AND IRRIGATED. ALL INCISIONS WERE CLOSED, AND A MAXFRAME RING FIXATOR WAS APPLIED TO STABILIZE THE FRACTURE. THE ORIGINAL DATE OF IMPLANTATION WAS UNKNOWN. THE PROCEDURE AND PATIENT OUTCOMES WERE UNKNOWN. THIS COMPLAINT INVOLVES SEVENTEEN (17) DEVICES. (B)(4).

  Patient problems: Tissue Damage

  MAUDE report 9983481 ↗