NA 02.130.312Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982045195), received between Nov 5, 2018 and Jun 28, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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.

• MalfunctionJun 28, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SCREW HEADS WERE NOT ABLE TO ENGAGE WITH SCREWDRIVER. EITHER STRIPPED OR DAMAGED. IT IS UNKNOWN IF THE PATIENT EXPERIENCED A POST-OP DEVICE MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1)2.0 VA-LCKNG SCR SLF-TPNG T6 SD REC 12 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14841806 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REMOVAL OF THE VARIABLE ANGLE (VA) LOCKING T-PLATE AND SCREWS DUE TO AN INFECTION. INITIALLY, THE PATIENT WAS IMPLANTED WITH THE REPORTED DEVICES ON (B)(6) 2019. DURING THE PROCEDURE, ALL THE ORIGINAL IMPLANTS WERE SUCCESSFULLY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT STATUS WAS UNKNOWN. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 9739008 ↗
• InjuryNov 5, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RADIAL NECK/HEAD UTILIZING THE VARIABLE ANGLE (VA) LOCKING Y-PLATE ON (B)(6 2018. IT WAS FURTHER REPORTED THE FIXATION DID NOT HOLD. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED THE Y-PLATE, FOUR (4) VA LOCKING SCREWS AND FOUR (4) CORTEX SCREWS. THIS REPORT IS FOR ONE (1) 2.0MM VA LOCKING SCREW. THIS IS REPORT 7 OF 9 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8037354 ↗
• InjuryNov 5, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RADIAL NECK/HEAD UTILIZING THE VARIABLE ANGLE (VA) LOCKING Y-PLATE ON (B)(6) 2018. IT WAS FURTHER REPORTED THE FIXATION DID NOT HOLD. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED THE Y-PLATE, FOUR (4) VA LOCKING SCREWS AND FOUR (4) CORTEX SCREWS. THIS REPORT IS FOR ONE (1) 2.0MM VA LOCKING SCREW. THIS IS REPORT 2 OF 9 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8037342 ↗