CHS 124126Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010072863), received between Mar 6, 2019 and Apr 17, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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. 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.

• InjuryApr 17, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A PLATE WAS IMPLANTED IN PATIENTS LEFT HIP DUE TO A BONE CYST IN (B)(6) 2009. PATIENT HAD ONGOING ISSUES WITH PAIN OVER THE YEARS; HOWEVER, PAIN INTENSIFIED IN 2019 TO THE POINT PATIENT NEEDED TO BE ON CRUTCHES. SHE ASKED FOR TWO DIFFERENT MEDICAL OPINIONS AND FOUND AN ORTHOPEDIC SURGEON WILLING TO TAKE JUST THE TOP SCREW WHICH LOOKED TO BE PARTIALLY OUT. DURING THE REVISION SURGERY, THEY FOUND THE COMPRESSING SCREW 28.5MM WASN'T EVEN IN, AND THEY JUST NEEDED TO GRAB IT OUT. THE PATIENT CONTINUED TO HAVE PAIN IN THE LEFT LEG. A TEST DONE FROM ORTHOPEDIC ANALYSIS SHOWS THAT THE PATIENT IS HYPERSENSITIVE TO NICKEL AND CHROMIUM AND FURTHER TESTING IS GOING TO BE INITIATED.

  Patient problems: Injury; Pain

  MAUDE report 9975114 ↗
• MalfunctionMar 6, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING SURGERY THE LAGSCREW INSITER WAS DAMAGED. SO IT DAMAGED THE LAGSCREW AND PLATE AS WELL. A BACKUP DEVICE WAS AVAILABLE AND MORE THAN 30 MINUTES OF DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8394921 ↗