DHS 280.800SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982176288), received between May 27, 2019 and May 27, 2019 — 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. 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.

• InjuryMay 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) AND HARDWARE REMOVAL DUE TO IMPLANTS NEED TO COME OUT FOR STAGING AND CONVERTED TO THE TOTAL HIP PROCEDURE. THE FOLLOWING DEVICES WERE INITIALLY IMPLANTED ON AN UNKNOWN DATE; ONE (1) RETROGRADE FEMORAL NAIL, ONE (1) 5.0MM/60MM TITANIUM LOCKING SCREW, ONE (1) 5.0MM/28MM TITANIUM LOCKING SCREW, UNKNOWN DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (DHS/DCS) PLATE, AND ONE (1) DHS/DCS LAG SCREW. NOTHING WAS BROKEN AND THERE WAS NO ISSUE ON THE DEVICES REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) DHS®/DCS® LAG SCREW 12.7MM THREAD/80MM-STERILE. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8644075 ↗