NA 02.205.280Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982050007), received between Jul 23, 2020 and Jun 15, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Slipped” (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 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.

• InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT DUE TO INFECTION THE PATIENT UNDERWENT FOR A REVISION SURGERY TO REMOVE DEFECTIVE FRACTURED 4.5 MM PROXIMAL TIBIAL PLATE AND OTHER ASSOCIATED SCREWS. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 5.0MM CANNULATED CONICAL SCREW 80MM THIS REPORT IS 4 OF 7 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection

  MAUDE report 12001932 ↗
• InjuryJul 23, 2020Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE PATIENT UNDERWENT THE REMOVAL OF OSTEOSYNTHESIS MATERIAL AND A CONDYLAR SUPPORT PLATE THAT HAD FAILED. THE DISTAL LOCKING SCREWS OF THE PLATE WERE LOOSE AND ONE WAS ALREADY EXPOSED OUTSIDE OF THE SKIN. AN ADDITIONAL REDUCTION WAS PERFORMED BUT THE SCREWS DID NOT BLOCK THE PLATE AND IT WAS DECIDED TO REMOVE ALL THE MATERIAL AND PUT A SPLINT IN ONE OF THE WOUNDS THAT WAS FOUND TO BE INFECTED. THE FIRST INTERVENTION WAS PERFORMED BECAUSE THE DISTAL SCREWS OF THE PLATE CAME OFF. THE SECOND OPERATION WAS PERFORMED TO EXTRACT A SCREW THAT WAS EXPOSED THROUGH THE SKIN AND THE THIRD INTERVENTION WAS WHEN ALL OF THE MATERIAL WAS REMOVED. THE FIRST TWO INTERVENTIONS WERE PERFORMED TO REMOVE THE IMPLANT AND TRY TO CORRECT THE NEW FRACTURE, IN THE LAST SURGERY IT WAS SHOWN THAT THERE WAS AN INFECTION. THIS REPORT IS FOR ONE (1) 5.0MM CANNULATED CONICAL SCREW 80MM. THIS IS REPORT 2 OF 9 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4)

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10312557 ↗