DHS 281.100SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982176592), received between May 29, 2018 and May 29, 2018 — 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.

• InjuryMay 29, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT HAD TO UNDERGO A HARDWARE REMOVAL SURGERY ON (B)(6) 2018 DUE TO A BROKEN PLATE. THE PATIENT WAS ORIGINALLY IMPLANTED WITH A 10-HOLE PLATE AND NINE SCREWS ON (B)(6) 2017 AS TREATMENT FOR A FEMUR FRACTURE. FOLLOWING THE IMPLANT PROCEDURE, THE PATIENT RETURNED HOME AND UNDERWENT 12 DAYS OF REHAB, 5 WEEKS OF HOME CARE AND BACK TO BACK VISITS TO A LOCAL ORTHOPEDIC SURGEON. DURING THE PATIENTS VISITS TO THE ORTHOPEDIC SURGEONS¿ OFFICE X-RAYS WERE TAKEN (NOT AVAILABLE) AND THE PATIENT WAS EVENTUALLY CLEARED TO BEGIN TO WALK, STAND, BEND AND SIT WITHOUT ASSISTANCE OR A WALKER. HOWEVER, FOLLOWING THIS CLEARANCE, ON FRIDAY (B)(6) 2018 APPROXIMATELY FOUR TO FIVE MONTHS FOLLOWING THE ORIGINAL IMPLANT PROCEDURE, THE PATIENT GOT UP FROM A CHAIR AND HEARD A POP. THE PATIENT IMMEDIATELY WENT TO THE ORTHOPEDIC SURGEON AND WAS NOTIFIED THE PLATE HAD BROKEN AT ONE OF THE SCREW HOLES. THE HOLE AT WHICH THE PLATE BROKE WAS NOT OCCUPYING A SCREW. THE ORTHOPEDIC SURGEON TOLD THE PATIENT THAT THE FEMUR HAD BROKEN YET AGAIN AND THAT THE NEW BREAK CAUSED THE PLATE TO BREAK. THE PATIENT UNDERWENT THE HARDWARE REMOVAL SURGERY ON (B)(6) 2018. DURING THAT REMOVAL PROCEDURE ALL HAR

  Patient problems: Failure of Implant

  MAUDE report 7548948 ↗