NA 412.211SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982275387), received between Aug 25, 2021 and Aug 25, 2021 — classified as 2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT HAD AN EX-PLANTATION OF A FAILED FEMORAL NECK SYSTEM, ORIGINAL DATE OF THE SURGERY WAS (B)(6) 2020. THE PATIENT HAS A HISTORY OF SUBSTANCE ABUSE. NO FRAGMENTATION WAS OBSERVED BESIDES THE SPLIT IN THE BOLT FOR FEMORAL NECK SYSTEM AND ANTI-ROTATION SCREW. CONCOMITANT DEVICE REPORTED: FEMORAL NECK SYSTEM (PART: 04.268.000S; LOT:22P9146; QUANTITY: 1). 5.0MM LOCKING SCREWS, WITH T25 STARDRIVE (PART:412.211S;LOT:4L80139 QUANTITY: 1). 5.0MM LOCKING SCREWS, WITH T25 STARDRIVE (PART:412.210S LOT# UNKNOWN; QUANTITY:1). THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 34MM-STERILE. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12367652 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT HAD AN EX-PLANTATION OF A FAILED FEMORAL NECK SYSTEM, ORIGINAL DATE OF THE SURGERY WAS (B)(6) 2020. THE PATIENT HAS A HISTORY OF SUBSTANCE ABUSE. NO FRAGMENTATION WAS OBSERVED BESIDES THE SPLIT IN THE BOLT FOR FEMORAL NECK SYSTEM AND ANTI-ROTATION SCREW. CONCOMITANT DEVICE REPORTED: FEMORAL NECK SYSTEM (PART: 04.268.000S; LOT:22P9146; QUANTITY: 1); 5.0MM LOCKING SCREWS, WITH T25 STARDRIVE (PART:412.211S;LOT:4L80139 QUANTITY: 1); 5.0MM LOCKING SCREWS, WITH T25 STARDRIVE (PART:412.210S LOT# UNKNOWN; QUANTITY:1). THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 34MM-STERILE. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12367650 ↗