NA 02.206.216Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982050946), received between May 24, 2019 and Nov 10, 2020 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, NONUNION OCCURRED AND 6-HOLE VA-LCP MEDIAL DISTAL PLATE WITH SIX 2.7MM VA LOCKING SCREWS, THREE 3.5 CORTICAL SCREWS, AND ONE 3.5 LOCKING SCREW WERE ALL REMOVED. THE SCREW HEAD MAY HAVE ALREADY BEEN BROKE PRIOR TO THE REMOVAL CASE. THERE WAS NO SURGICAL DELAY REPORTED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWELVE (12) DEVICES. THIS REPORT IS FOR (1) LWPROF CORT CR ø3.5 SELF-TAP L16 SST. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10818368 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, NONUNION OCCURRED AND 6-HOLE VA-LCP MEDIAL DISTAL PLATE WITH SIX 2.7MM VA LOCKING SCREWS, THREE 3.5 CORTICAL SCREWS, AND ONE 3.5 LOCKING SCREW WERE ALL REMOVED. THE SCREW HEAD MAY HAVE ALREADY BEEN BROKE PRIOR TO THE REMOVAL CASE. THERE WAS NO SURGICAL DELAY REPORTED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWELVE (12) DEVICES. THIS REPORT IS FOR (1) LWPROF CORTSCR ø3.5 SELF-TAP L16 SST. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10818349 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, NONUNION OCCURRED AND 6 HOLE VA-LCP MEDIAL DISTAL PLATE WITH SIX 2.7MM VA LOCKING SCREWS, THREE 3.5 CORTICAL SCREWS, ONE 3.5 LOCKING SCREW WERE ALL REMOVED AND ONE UNKNOWN BROKEN 2.7MM VA LOCKING SCREW THAT WAS LEFT IN THE DISTAL PORTION OF THE TIBIA. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. THE PROCEDURE AND PATIENT OUTCOMES WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/STRDRV/16MM-STER. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).

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

  MAUDE report 10816713 ↗
• InjuryMay 24, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 7 OF 10 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 7 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4) FOR ADDITIONAL DEVICES.

  Patient problems: Bone Fracture(s); Nonunion/Delayed-union Bone Fracture

  MAUDE report 8640399 ↗