LCP 03.120.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982074003), received between Oct 27, 2020 and Jun 27, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 THE PRIOR TO THE PROCEDURE, THE SCRUB TECH WAS ASSEMBLING THE AIMING ARM INSTRUMENTS. AFTER DETERMINING THE PLATE TO USE, THE SCRUB TECH CONNECTED THE AIMING ARM INSTRUMENTS TO THE PLATE IN ORDER TO "BUILD THE BOX". THIS WAS UNSUCCESSFUL. AFTER MULTIPLE ATTEMPTS OF DISASSEMBLING AND REASSEMBLING THE AIMING INSTRUMENTS, WE WERE UNABLE TO PROPERLY ALIGN THE AIMING ARM INSTRUMENTS WITH THE PLATE. WE PROCEEDED WITH THE PROCEDURE WITHOUT USING THE AIMING ARM INSTRUMENTATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAYS, NEGATIVE OUTCOMES, OR INTERVENTION REQUIRED. AFTER THE PROCEDURE WAS OVER, IT WAS DETERMINED THAT THE AIMING ARM INSTRUMENTATION WAS DEFECTIVE. THIS REPORT IS FOR ONE (1) COUPLING BOLT LCP PERIARTICULAR AIM ARMS THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630170 ↗
• MalfunctionNov 15, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE PERFORMING A PROXIMAL TIBIA, THE SURGEON FELT THERE WAS ISSUES WITH THE AIMING ARM BECAUSE THE THREADED TOWERS WERE NOT ABLE TO REACH THE PLATE. ONCE THE SURGEON PUSHED HARDER, THE TOWERS WERE ABLE TO ENGAGE INTO THE PLATE. IT APPEARS THAT WHEN THE PLATE WAS PULLED TO THE BONE WITH A SCREWS, IT PULLED THE PLATE AWAY FROM THE HANDLE AND FURTHER AWAY FROM THE TOWER. THE SURGERY WAS SUCCESSFULLY COMPLETED. SALES REPRESENTATIVE SPOKE WITH THE SURGEON AFTER THE CASE AND SAID THIS HANDLE REPLACED IN CASE THERE WAS AN ISSUES WITH AIMING ARM. THE HANDLE WAS NOT LINING UP WITH THE PLATE HOLES. IT WAS CHECKED PRIOR TO INSERTION AND IT LINED UP, HOWEVER INTRA-OP, AFTER PLATE WAS BROUGHT TO BONE , IT DID NOT LINE UP. NO ADVERSE EVENTS OCCURRED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: UNK - PLATES: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) AND UNK - SCREWS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) PERIART INSRT HNDL 4.5 LCP PRX TIB PL-RT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15796761 ↗
• InjuryOct 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  THE SURGERY WAS COMPLETED SUCCESSFULLY BY EXTENDING THE INCISION.

  Patient problems: No Code Available; Tissue Damage; Unspecified Tissue Injury

  MAUDE report 10742367 ↗