VA-LCP 02.117.104Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982035905), received between Jul 3, 2018 and Mar 13, 2024 — classified as 1 injury, 3 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PLATES WERE IMPLANTED IN THE PATIENT, THE LOCKING SCREWS DID NOT LOCK IN 1-2 HOLES OF THE PL AND MEDIAL PLATES SO THOSE PLATE HOLES WERE NOT FILLED. THE SURGEON INITIALLY USED A VA GUIDE BUT LATER USED A NON LOCKING DRILL GUIDE. UNSURE IF IT¿S BECAUSE HE USED A METAPHYSEAL SCREW FIRST TO SUCK THE PLATE DOWN, AND THEN CHANGED FOR A VAL. WE¿VE HAD ISSUES WITH THIS PLATE NOT LOCKING, SURGEON DID NOT WANT PATIENT TO BE CHARGED. WHILE INSERTING CORTICAL SCREWS AND A 7.3 CANNULATED FOR THE OLECRANON OSTEOTOMY HE ALSO COMPLAINED OF THE SCREWDRIVER HEADS BEING STRIPPED OR WARPED. THERE WERE NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) 2.7/3.5 VA PSTLT DHP-LAT SUPT 4H/L/88-MD THIS IS REPORT 2 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18897653 ↗
• MalfunctionAug 24, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN EVENT OCCURRED WHERE THE LOCKING SCREW DID NOT LOCK INTO A VA POSTEROLATERAL PLATE. TWO HOLES SEEMED STRIPED. THERE WAS A DELAY OF UNKNOWN LENGTH. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONALLY, ON THE AUX TRAY ½ WIDTH, THERE WAS BLACK RESIDUE FROM CEMENT THAT DID NOT COME OFF INTRAOPERATIVELY. THIS REPORT INVOLVES ONE 2.7MM/3.5MM VA-LCP POSTLAT DHP-LAT SUPT 4H/LT/88MM-MED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612006 ↗
• InjuryJun 11, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO PAIN. ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE POSTEROLATERAL DISTAL HUMERUS PLATES WITH LATERAL SUPPORT, ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE EXTENDED MEDIAL DISTAL HUMERUS PLATES, ONE (1) CORTEX SCREW SELF-TAPPING 50 MM, ONE (1) CORTEX SCREW SELF-TAPPING 20 MM, ONE (1) CORTEX SCREW SELF-TAPPING 24 MM, THREE (3) CORTEX SCREWS SELF-TAPPING 20 MM, ONE (1) CORTEX SCREW SELF-TAPPING 22 MM, ONE (1) CORTEX SCREW SELF-TAPPING 26 MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14 MM, ONE VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16 MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 22 MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 30 MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 40 MM AND ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 50 MM. SOME SCREWS WERE BROKEN AND LEFT. OTHER SCREWS WERE LEFT IN THE BODY. IT IS UNKNOWN IF WHAT SCREWS WERE LEFT/BROKEN. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY

  Patient problems: No Code Available; Pain

  MAUDE report 8686958 ↗
• MalfunctionJul 3, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) LEFT DISTAL HUMERUS FRACTURE ON (B)(6) 2018. DURING THE PROCEDURE, THE MEASUREMENT OF THE DEPTH GAUGE FOR SCREWS WAS 5MM WHICH WAS TOO SHORT. A SECOND SET WAS OPENED FOR ANOTHER DEPTH GAUGE AND THE SURGEON EXPRESSED THE SAME PROBLEM WITH THE SECOND ONE. IT WAS ALSO REPORTED THAT THE THREE (3) VARIABLE ANGLE (VA) LOCKING SCREWS WERE WASTED. ALL THREE SCREWS WERE REMEASURED TO CONFIRM LENGTH. THE VA LOCKING SCREW WOULD NOT LOCK INTO THE MOST DISTAL-LATERAL HOLE OF THE PLATE. THE SURGEON TRIED TO REMOVE IT BUT THE SCREW JUST SPUN IN THE LOCKING HOLE WITHOUT RETRACTING OUT. THE SURGEON CONTINUED TO IMPLANT THE PLATE BECAUSE THE REDUCTION AND THE REST OF THE FIXATION WERE GOOD. THE SCREW WAS ALSO REMAINED IMPLANTED BECAUSE IT WOULD NOT GET OUT WITHOUT TAKING THE PLATE OFF. THERE WERE 5-10 MINUTES OF SURGICAL DELAY. THE PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN VARIABLE ANGLE LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 3) THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7658612 ↗