NA 02.205.080Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982049780), received between Jan 23, 2019 and Oct 7, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

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.

• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2020, DUE TO WOUND BREAKDOWN. ORIGINAL IMPLANT DATE UNKNOWN. THE PATIENT UNDERWENT REMOVAL OF ALL HARDWARE AND NO FRAGMENTS WERE GENERATED. ALL HARDWARE WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE IS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS UNKNOWN. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: Wound Dehiscence

  MAUDE report 10643920 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6)2020, DUE TO WOUND BREAKDOWN. ORIGINAL IMPLANT DATE UNKNOWN. THE PATIENT UNDERWENT REMOVAL OF ALL HARDWARE AND NO FRAGMENTS WERE GENERATED. ALL HARDWARE WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION.. THERE IS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS UNKNOWN. THIS IS REPORT 7 OF 10 FOR (B)(4).

  Patient problems: Wound Dehiscence

  MAUDE report 10643562 ↗
• 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 80MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8272078 ↗
• 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 80MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8272003 ↗