LCP 03.122.007Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982074553), received between Jun 8, 2018 and Jul 29, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PHILOS AIMING ARM DOESN'T MATCH THE HOLES OF THE PHILOS PLATE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. A NEW INSTRUMENT SET WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641847 ↗
• MalfunctionJun 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT TRAUMA SURGERY ON (B)(6) 2025. DURING THE PROCEDURE, THE PHILOS AIMING ARM DID NOT MEET THE SCREW HOLES OF THE PHILOS PLATE. ANOTHER AIMING ARM WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF TEN MINUTES. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167647 ↗
• MalfunctionMar 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PHILOS AIMING ARM DID NOT WORK PROPERLY. THE SHAFT HOLES DID NOT MATCH THE PLATE HOLES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21505769 ↗
• MalfunctionJul 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE NETHERLANDS REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE PERCUTANEOUS PLATING (MIPO) PROCEDURE ON (B)(6) 2023, THE PHILOS AIMING ARM DIDN'T AIM AT THE HOLES ON THE PHILOS PLATE. PROCEDURE WAS COMPLETED WITH A FIFTEEN MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN AIMING ARM F/LCP PROXIMAL HUMERUS PLATE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397401 ↗
• MalfunctionJul 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE NETHERLANDS REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE PERCUTANEOUS PLATING (MIPO) PROCEDURE ON (B)(6) 2023 THE PHILOS AIMING ARM DIDN'T AIM AT THE HOLES ON THE PHILOS PLATE. PROCEDURE WAS COMPLETED WITH A FIFTEEN MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN AIMING ARM F/LCP PROXIMAL HUMERUS PLATE. THIS IS REPORT 1 OF 3 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397151 ↗
• MalfunctionApr 25, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PROXIMAL HUMERUS AIMING ARM MISALIGNED WITH THE PLATE CAUSING TROCARS TO MISFIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES/OUTCOME. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) AIMING ARM F/LCP PROXIMAL HUMERUS PLATE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811582 ↗
• InjuryJun 8, 2018Failure to Align; Failure to Align

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE SURGERY ON (B)(6) 2018, PROPERLY LOCKING OF IMPLANTS WITH AIMING ARM WAS NOT POSSIBLE. THE GUIDING DEVICE AND AIMING ARM WERE AFFECTED. IN A FIRST STEP GUIDING DEVICE HAD BEEN CHANGED. THIS DID NOT IMPROVE THE SITUATION. AIMING ARM WAS CHANGED IN A SECOND STEP. THE SURGERY WAS PROLONGED ABOUT 15 MINUTES AS THEY SWITCHED FROM LAPAROSCOPIC TO OPEN. SURGERY WAS COMPLETED SUCCESSFULLY. WHEN DEVICES WERE TESTED PRE-OPERATIVE, DRILL GUIDE IN GUIDING DEVICE AND HOLE DID NOT CORRESPOND. CONCOMITANT DEVICE REPORTED: PHILOS PLATE (PART# 441.903, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) AIMING ARM F/LCP PROXIMAL HUMERUS PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7584313 ↗