LCP 441.903Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982222466), received between Apr 21, 2023 and Apr 21, 2023 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: YU, RF. ET AL., (2019), A COMPARISON OF THE NEW BONE CEMENT REINFORCED SCREW WITH LOCK SHEET STEEL FIXATION AND ARTIFICIAL HUMERUS REPLACEMENT FOR PROXIMAL OSTEOPOROSIS FRACTURE TREATMENT OF HUMERUS, CHINESE JOURNAL OF TISSUE ENGINEERING RESEARCH, VOL. 15 (XX) PAGES 2335-2339. (CHINA). THE AIM OF THIS RETROSPECTIVE CASE ANALYSES WAS TO COMPARE THE CLINICAL EFFICACY OF THE NEW BONE CEMENT SCREW TECHNOLOGY COMBINED WITH FIXED IN LOCKED STEEL PLATE AND ARTIFICIAL HUMERUS BONE REPLACEMENT IN THE TREATMENT OF A PROXIMAL OSTEOPOROTIC FRACTURE OF THE HUMERUS. BETWEEN FEBRUARY 2017 TO MARCH 2019, A TOTAL OF 22 PATIENTS WITH OSTEOPOROTIC FRACTURES OF THE PROXIMAL WERE INCLUDED IN THE STUDY, INCLUDING 8 MALES AND 14 FEMALES, AGED 68-88 YEARS. 10 PATIENTS UNDERWENT OPEN REDUCTION USING NEW CEMENT-REINFORCED SCREWS COMBINED WITH LOCKING PLATE INTERNAL FIXATION (INTERNAL FIXATION GROUP), AND 12 PATIENTS UNDERWENT HUMERAL HEAD ARTHROPLASTY (HUMERAL HEAD ARTHROPLASY GROUP). THIS STUDY WAS TREATED WITH BONE CEMENT REINFORCED SCREW TECHNOLOGY USING CUT-OPEN

  Patient problems: Loss of Range of Motion

  MAUDE report 16787505 ↗