NA 02.205.070Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982049766), received between May 8, 2018 and Jan 23, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2019Material Twisted/Bent; Migration; Material Twisted/Bent; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REMOVAL SURGERY ON (B)(6) 2018. ONE (1) 70MM CANNULATED VARIABLE ANGLE (VA) LOCKING SCREW, ONE (1) 75MM CANNULATED VA LOCKING SCREWS, TWO (2) 80MM CANNULATED VA LOCKING SCREWS AND ONE (1) 85MM CANNULATED VA LOCKING SCREW HAD BACKED OUT OF THE CONDYLAR PLATE AND WERE REMOVED. THE PLATE WAS RETAINED, AND NEW SCREWS WERE ADDED. THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) CONDYLAR PLATE WAS ORIGINALLY IMPLANTED ON (B)(6) 2018. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: CONDYLAR PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY 1), LOCKING SPINE SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A 5.0MM CANNULATED LOCKING SCREW 70MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8271869 ↗
• InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4), A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. THIS REPORT CAPTURES ONE 5.0MM CANNULATED LOCKING SCREW 70MM. THIS IS REPORT 10 OF 10 FOR (B)(4). THE OTHER SCREW IS BEING CAPTURED ON RELATED (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7497922 ↗
• InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4) , A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. THIS REPORT CAPTURES ONE 5.0MM CANNULATED LOCKING SCREW 70MM. THIS IS REPORT 3 OF 10 FOR (B)(4). THE OTHER SCREW IS BEING CAPTURED ON RELATED (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7497908 ↗
• InjuryMay 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4), A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. THIS REPORT CAPTURES ONE CANNULATED LOCKING SCREW. THE OTHER SCREWS AND PLATE ARE BEING CAPTURED ON RELATED COMPLAINT (B)(4). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7495236 ↗