NA 208.850Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982149930), received between Apr 17, 2019 and Apr 17, 2019 — classified as 2 injuries.

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 18, 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, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF 7.3MM CANNULATED SCREW 16MM THREAD/50MM, 7.3MM CANNULATED SCREW 16MM THREAD/55MM AND PLATE FROM PROXIMAL FEMUR AND REVISED TO 130 DEGREE BLADE PLATE DUE TO MALUNION/NONUNION AND POSSIBLE INFECTION DUE TO GUNSHOT WOUND. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT CAPTURES THE POST-OP EVENT WHILE (B)(4) CAPTURES THE INTRA-OP EVENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 7.3MM CANNULATED SCREW 16MM THREAD/55MM. THIS REPORT IS 2 OF 3 FOR (B)(4).

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

  MAUDE report 8524762 ↗
• InjuryApr 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF 7.3MM CANNULATED SCREW 16MM THREAD/50MM, 7.3MM CANNULATED SCREW 16MM THREAD/55MM AND PLATE FROM PROXIMAL FEMUR AND REVISED TO 130 DEGREE BLADE PLATE DUE TO MALUNION/NONUNION AND POSSIBLE INFECTION DUE TO GUNSHOT WOUND. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT CAPTURES THE POST-OP EVENT WHILE (B)(4) CAPTURES THE INTRA-OP EVENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 7.3MM CANNULATED SCREW 16MM THREAD/50MM. THIS REPORT IS 1 OF 3 FOR (B)(4).

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

  MAUDE report 8524761 ↗