DHS 280.310Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982175250), received between Oct 11, 2019 and Oct 11, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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

• InjuryOct 11, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A NONUNION AND A BROKEN LAG SCREW. INITIALLY THE PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION (ORIF) FOR AN INTERTROCHANTERIC FRACTURE USING WITH A 4 HOLE DYNAMIC HIP SYSTEM (DHS), ONE 12.7MM LAG SCREW AND THREE 4.5MM CORTEX SCREWS IN (B)(6) 2018. HOWEVER, ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE A NON-UNION OF THE INTERTROCHANTERIC FRACTURE AND BREAKAGE OF THE 12.7MM LAG SCREW AT THE MEDIAL TIP OF THE DHS SIDE PLATE BARREL. THUS, A REVISION PROCEDURE WAS DONE WHEREIN ALL THE EXISTING IMPLANTS AND FRAGMENTS WERE REMOVED UNEVENTFULLY. THEN, THE PATIENT WAS REVISED WITH A 95-DEGREE BLADE PLATE (9 HOLE SHAFT - 80MM BLADE LENGTH) AND FIVE 4.5 CORTEX SCREWS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: DHS PLATE (PART # 281.140, LOT # 9323622, QUANTITY 1), CORTEX SCREW (PART # 214.840, LOT # UNKNOWN, QUANTITY 3). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/110MM THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 9182872 ↗