NA 04.005.566Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982086341), received between Jul 19, 2022 and Apr 10, 2023 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT HARDWARE REMOVAL DEEP DUE TO RIGHT FEMUR PAINFUL HARDWARE. THE PLATE SCREWS AND STIMULATOR BODIES WERE REMOVED. THE STIMULATOR ELECTRODES WERE ENCASED IN BONE AND WERE NOT EXTRACTED. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCR T25 SD 76 FOR IM NAILS. THIS IS REPORT 9 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 16709647 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT HARDWARE REMOVAL DEEP DUE TO RIGHT FEMUR PAINFUL HARDWARE. THE PLATE SCREWS AND STIMULATOR BODIES WERE REMOVED. THE STIMULATOR ELECTRODES WERE ENCASED IN BONE AND WERE NOT EXTRACTED. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCR T25 SD 76 FOR IM NAILS. THIS IS REPORT 6 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 16709639 ↗
• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) [SUMMARY OF RETROSPECTIVE DATA FOR PATIENTS TREATED WITH THE LATERAL FEMORAL NAIL, ADOLESCENT LATERAL FEMORAL NAIL, AND THE FEMORAL RECON NAIL]. BETWEEN JANUARY 2014 AND OCTOBER 2021, A TOTAL OF 300 PATIENTS (219 PATIENTS TREATED WITH LFN, 56 PATIENTS TREATED WITH ALFN, AND 25 PATIENTS TREATED WITH FRN) WERE INCLUDED IN THE REPORT IF THEY HAD EITHER 9 MONTHS OF FOLLOW-UP OR EVIDENCE OF HEALING. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED IN THE (B)(6) HOSPITAL¿S ORTHOPEDIC INPATIENT DATABASE: LFN GROUP: PATIENT 5: A 32-YEAR-OLD MALE PATIENT HAD A WEAKNESS IN LEG, WHICH RESOLVED WITH PHYSICAL THERAPY. PATIENT 6: AN 81-YEAR-OLD MALE PATIENT HAD A PERSISTENT SWELLING ABOUT KNEE 1.5 YEARS POSTOPERATIVELY, COMPRESSION. PATIENT 8: A 58-YEAR-OLD FEMALE PATIENT HAD A PULMONARY EMBOLISM. PATIENT 9: A 35-YEAR-OLD FEMALE PATIENT HAD DIFFICULT REDUCTION INTRAOPERATIVELY AND HAD RESIDUAL SORENESS AT INCISION SITE POSTOPERATIVELY. PATIENT 13: A 16-YEAR-OLD MALE PATIENT HAD PAIN WITH IMPLANTS LEADING TO REHOSPITALIZATION FOR ADJUNCTIVE PLATE REMOVAL, LFN WAS NOT

  Patient problems: Adhesion(s)

  MAUDE report 15065521 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) [SUMMARY OF RETROSPECTIVE DATA FOR PATIENTS TREATED WITH THE LATERAL FEMORAL NAIL, ADOLESCENT LATERAL FEMORAL NAIL, AND THE FEMORAL RECON NAIL]. BETWEEN JANUARY 2014 AND OCTOBER 2021, A TOTAL OF 300 PATIENTS (219 PATIENTS TREATED WITH LFN, 56 PATIENTS TREATED WITH ALFN, AND 25 PATIENTS TREATED WITH FRN) WERE INCLUDED IN THE REPORT IF THEY HAD EITHER 9 MONTHS OF FOLLOW-UP OR EVIDENCE OF HEALING. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED IN THE BRONSON METHODIST HOSPITAL¿S ORTHOPEDIC INPATIENT DATABASE: LFN GROUP: PATIENT 5: A 32-YEAR-OLD MALE PATIENT HAD A WEAKNESS IN LEG, WHICH RESOLVED WITH PHYSICAL THERAPY. PATIENT 6: AN 81-YEAR-OLD MALE PATIENT HAD A PERSISTENT SWELLING ABOUT KNEE 1.5 YEARS POSTOPERATIVELY, COMPRESSION. PATIENT 8: A 58-YEAR-OLD FEMALE PATIENT HAD A PULMONARY EMBOLISM. PATIENT 9: A 35-YEAR-OLD FEMALE PATIENT HAD DIFFICULT REDUCTION INTRAOPERATIVELY AND HAD RESIDUAL SORENESS AT INCISION SITE POSTOPERATIVELY. PATIENT 13: A 16-YEAR-OLD MALE PATIENT HAD PAIN WITH IMPLANTS LEADING TO REHOSPITALIZATION FOR ADJUNCTIVE PLATE REMOVAL, L

  Patient problems: Fatigue

  MAUDE report 15053962 ↗