NA 413.028Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982211798), received between May 16, 2023 and May 16, 2023 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K000684); they may or may not involve this specific model.

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.

• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SOUTH KOREA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN DECEMBER OF 2022, THE PLATE AND SCREWS IN QUESTION WERE IMPLANTED TO FIX BONE AND/OR LIGAMENT JOINTS AFTER TRAUMA CAUSED BONE FRACTURES AND DAMAGE TO JOINT LIGAMENTS. AT AN UNKNOWN POINT AFTER THE INITIAL SURGERY, AN INFECTION OCCURRED, SO PLATE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2023. DURING THE REVISION PROCEDURE, IT WAS DISCOVERED THAT A SCREW HEAD HAD BROKEN AND DISCONNECTED FROM THE REST OF THE SCREW. THIS MADE IT DIFFICULT TO REMOVE THE SCREW, WHICH INCREASED THE OPERATION TIME. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR A 3.5MM TI LOCKING SCREW SELF-TAPPING 28MM. THIS IS REPORT 1 OF 14 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16940402 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SOUTH KOREA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2022, THE PLATE AND SCREWS IN QUESTION WERE IMPLANTED TO FIX BONE AND/OR LIGAMENT JOINTS AFTER TRAUMA CAUSED BONE FRACTURES AND DAMAGE TO JOINT LIGAMENTS. AT AN UNKNOWN POINT AFTER THE INITIAL SURGERY, AN INFECTION OCCURRED, SO PLATE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2023. DURING THE REVISION PROCEDURE, IT WAS DISCOVERED THAT A SCREW HEAD HAD BROKEN AND DISCONNECTED FROM THE REST OF THE SCREW. THIS MADE IT DIFFICULT TO REMOVE THE SCREW, WHICH INCREASED THE OPERATION TIME. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR A 3.5MM TI LOCKING SCREW SELF-TAPPING 28MM. THIS IS REPORT 9 OF 14 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16940390 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,