LCP 02.104.026Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982029126), received between May 13, 2021 and Nov 14, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 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.

• MalfunctionNov 14, 2022Material Deformation; Material Deformation

  IT WAS REPORTED ON UNKNOWN EVEN DATE THAT POST OP INSPECTION OCCURRED GRAPHIC CASE HAD WHITE SANDY DUE TO VOLUME OF USAGE AND PEELING OF GRAPHIC CASE. SHORT POWER SHAFTS WERE WARPED DUE TO USAGE, AND KEPT STRIPPING SCREWS. CONNECTING ELEMENT THREADS WERE STRIPPED AFTER USAGE. PLATES WERE BENT AFTER WASH FROM CSPD. NO PATIENT AND PROCEDURE OUTCOME AND NO SURGICAL DELAY REPORTED BECAUSE IT IS A POST OF EVENT. THIS REPORT IS FOR ONE (1)3.5 LCP X-ARTC DSTL HUM PL 6H/LT 158 LG. THIS IS REPORT 5 OF 6 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15792795 ↗
• MalfunctionNov 14, 2022Material Deformation; Material Deformation

  IT WAS REPORTED ON UNKNOWN EVEN DATE THAT POST OP INSPECTION OCCURRED GRAPHIC CASE HAD WHITE SANDY DUE TO VOLUME OF USAGE AND PEELING OF GRAPHIC CASE. SHORT POWER SHAFTS WERE WARPED DUE TO USAGE, AND KEPT STRIPPING SCREWS. CONNECTING ELEMENT THREADS WERE STRIPPED AFTER USAGE. PLATES WERE BENT AFTER WASH FROM CSPD. NO PATIENT AND PROCEDURE OUTCOME AND NO SURGICAL DELAY REPORTED BECAUSE IT IS A POST OF EVENT. THIS REPORT IS FOR ONE (1) .5 LCP X-ARTC DSTL HUM PL 6H/LT 158 LG THIS IS REPORT 2 OF 6 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15791779 ↗
• InjuryMay 13, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT HARDWARE REMOVAL AND RE-PLATING. PATIENT FELL AND BROKE THE PLATE. IT IS UNKNOWN IF THERE IS SURGICAL DELAY REPORTED AND IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS FOR 1 3.5 LCP X-ARTC DSTL HUM PL 6H/LT 158 LG. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Fall

  MAUDE report 11821066 ↗