NA 02.130.212Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982044662), received between Sep 6, 2019 and Apr 1, 2020 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING OPEN REDUCTION INTERNAL FIXATION OF THE HAND, THE FIVE (5) VARIABLE ANGLE LOCKING SCREWS WOULD NOT LOCK IN THE VARIABLE ANGLE STRUT PLATE. THE SURGEON THEN HAD TO REMOVE THE PLATE AND CHOOSE A DIFFERENT PLATE TO COMPLETE THE SURGERY. THE TWO (2) SCREWS WHICH THE VARIABLE ANGLE LOCKING SCREWS WERE TRIED IN THE SAME COMPROMISED HOLE OF VARIABLE ANGLE STRUT PLATE. WHILE, THE THREE (3) OTHER SCREWS WERE WASTED AFTER THE SURGEON REQUESTED NEW SCREWS FOR THE NEW PLATE. THE SURGEON FELT THE SCREW HEADS WERE COMPROMISED AND DID NOT WANT TO DAMAGE THE NEW PLATE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS AND OUTCOME WERE SUCCESSFUL AFTER AN ALTERNATIVE PLATE WAS USED. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9913244 ↗
• MalfunctionApr 1, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING OPEN REDUCTION INTERNAL FIXATION OF THE HAND, THE FIVE (5) VARIABLE ANGLE LOCKING SCREWS WOULD NOT LOCK IN THE VARIABLE ANGLE STRUT PLATE. THE SURGEON THEN HAD TO REMOVE THE PLATE AND CHOOSE A DIFFERENT PLATE TO COMPLETE THE SURGERY. THE TWO (2) SCREWS WHICH THE VARIABLE ANGLE LOCKING SCREWS WERE TRIED IN THE SAME COMPROMISED HOLE OF VARIABLE ANGLE STRUT PLATE. WHILE, THE THREE (3) OTHER SCREWS WERE WASTED AFTER THE SURGEON REQUESTED NEW SCREWS FOR THE NEW PLATE. THE SURGEON FELT THE SCREW HEADS WERE COMPROMISED AND DID NOT WANT TO DAMAGE THE NEW PLATE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS AND OUTCOME WERE SUCCESSFUL AFTER AN ALTERNATIVE PLATE WAS USED. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9913204 ↗
• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL FOR A FINGER SURGERY. A VARIABLE ANGLE LOCKING PLATE FOR METACARPAL, ONE (1) CORTEX SCREW AND SIX (6) LOCKING SCREWS WERE REMOVED FROM THE PATIENT DUE TO POSSIBLE INFECTION AND REGRESSION OF THE FUSION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 8969737 ↗
• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL FOR A FINGER SURGERY. A VARIABLE ANGLE LOCKING PLATE FOR METACARPAL, ONE (1) CORTEX SCREW AND SIX (6) LOCKING SCREWS WERE REMOVED FROM THE PATIENT DUE TO POSSIBLE INFECTION AND REGRESSION OF THE FUSION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 8969680 ↗
• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AUGUST 8,2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL FOR A FINGER SURGERY. A VARIABLE ANGLE LOCKING PLATE FOR METACARPAL, ONE (1) CORTEX SCREW AND SIX (6) LOCKING SCREWS WERE REMOVED FROM THE PATIENT DUE TO POSSIBLE INFECTION AND REGRESSION OF THE FUSION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 8969599 ↗
• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL FOR A FINGER SURGERY. A VARIABLE ANGLE LOCKING PLATE FOR METACARPAL, ONE (1) CORTEX SCREW AND SIX (6) LOCKING SCREWS WERE REMOVED FROM THE PATIENT DUE TO POSSIBLE INFECTION AND REGRESSION OF THE FUSION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 8969530 ↗
• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL FOR A FINGER SURGERY. A VARIABLE ANGLE LOCKING PLATE FOR METACARPAL, ONE (1) CORTEX SCREW AND SIX (6) LOCKING SCREWS WERE REMOVED FROM THE PATIENT DUE TO POSSIBLE INFECTION AND REGRESSION OF THE FUSION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 8969487 ↗
• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL FOR A FINGER SURGERY. A VARIABLE ANGLE LOCKING PLATE FOR METACARPAL, ONE (1) CORTEX SCREW AND SIX (6) LOCKING SCREWS WERE REMOVED FROM THE PATIENT DUE TO POSSIBLE INFECTION AND REGRESSION OF THE FUSION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 8969461 ↗