VA-LCP 02.111.631Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982032010), received between May 11, 2017 and Jul 31, 2023 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K083694); they may or may not involve this specific model.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE SURGEON WAS PLACING A DISTAL RADIUS PLATE. AFTER SEVERAL SCREW EXCHANGES, THE SURGEON WAS NOT ABLE TO GET A LOCKING SCREW TO LOCK INTO THE PLATE AND ENDED UP PLACING A CORTEX SCREW INSTEAD. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR AN UNKNOWN DISTAL RADIUS PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17427274 ↗
• MalfunctionSep 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, THE VARIABLE ANGLE LOCKING SCREW WAS POWERED THROUGH THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS PLATE, WHILE PUTTING A SCREW IN THE POWER IN THE LEFT WRIST OF THE SCREW WENT TO THE PLATE. THE SCREW WAS REMOVED BY CONTINUING TO PUSH ALL THE WAY THROUGH AND REMOVED THE DORSAL, ON THE OTHER SIDE OF THE WRIST. THIS REPORT IS FOR (1) 2.4 VA 2-CLMN VLR DRP 6H HD/3H SFT/LFT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548765 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF A ONE (1) VARIABLE ANGLE (VA) DISTAL RADIUS PLATE, THREE (3) UNKNOWN CORTEX SCREW, AND SIX (6) LOCKING SCREW. THE SURGEON WAS NOTIFIED THAT HE ORIGINALLY PUT THE PLATE MORE DISTAL THAN NORMAL BECAUSE OF DISTAL FRACTURE. THE SURGEON WAS CONCERNED IT WOULD IRRITATE THE PATIENT IN THE FUTURE BECAUSE OF EXTREME DISTAL PLACEMENT OF THE PLATE AND AS A PRECAUTION DECIDED TO REMOVE THE CONSTRUCT. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE IMPLANTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT. NO PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 10 FOR PC-(B)(4).

  Patient problems: No Code Available

  MAUDE report 9418164 ↗
• InjuryJul 12, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2018, THE VARIABLE ANGLE LOCKING SCREW DID NOT LOCK INTO THE VOLAR DISTAL RADIUS PLATE. IT WAS UNKNOWN WHERE THE ISSUE WAS OBSERVED. HARDWARE REMOVAL WAS PERFORMED DUE TO THE SCREW NOT LOCKING INTO THE PLATE. IT WAS REPORTED THAT DEVICE WAS EXPLANTED ON AN UNKNOWN DATE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7681211 ↗
• MalfunctionMay 7, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY. THE PATIENT WAS BEING IMPLANTED WITH A VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) TWO-COLUMN VOLAR DISTAL RADIUS PLATE. DURING THE SURGERY, IT WAS NOTED THAT THE LOCKING SCREW FAILED TO LOCK IN MOST DISTAL LOCKING HOLE ON THE SHAFT OF THE PLATE. THE FAILED SCREW WAS DISCARDED. THE PLATE WAS FIXED USING OTHER NINE (9) 2.4 VARIABLE ANGLE LOCKING SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT OUTCOME WAS NOT REPORTED. THIS REPORT IS FOR ONE (1) 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/3H SHAFT/LEFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7491744 ↗
• MalfunctionMar 28, 2018Break; Break

  IT WAS REPORTED THAT THE SCREW WENT THROUGH THE PLATE INTO THE PATIENTS BONE AND THE VARIABLE ANGLE TABS IN THE PLATE BROKE WHILE INSERTING THE SCREW DURING A LEFT DISTAL RADIUS PROCEDURE ON (B)(6) 2018. THE BROKEN FRAGMENTS WERE REMOVED EASILY WITHOUT ANY DIFFICULTY. THE PLATE AND SCREW WERE REMOVED AND A NEW PLATE WAS INSERTED. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF ABOUT 10 MINUTES. THE PATIENT WAS STABLE AFTER THE SURGERY. THIS COMPLAINT INVOLVES TWO (2) DEVICES. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7379976 ↗
• MalfunctionFeb 21, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A DISTAL RADIUS FRACTURE PROCEDURE ON (B)(6) 2018, THE SURGEON NOTED A MALFUNCTION OF A DISTAL VARIABLE ANGLE PLATE. AS THE SURGEON WAS PLACING THE FIRST DISTAL VARIABLE ANGLE BUTTRESS PIN HE INDICATED THAT IT WOULD NOT LOCK INTO THE PLATE DESPITE THE APPROPRIATE DRILL GUIDE BEING USED. ON A VISUAL INSPECTION OF THE HOLE IN THE PLATE, THE SURGEON NOTED THAT IT DID NOT LOOK AS HE EXPECTED. ANOTHER PLATE WAS SELECTED AND USED WITH THE CONCOMITANT SURGICAL DEVICES; THE DRILL GUIDE, DRILL BIT, AND BUTTRESS PIN. ALL DEVICES (USED ALSO WITH THE FIRST PLATE) FUNCTIONED AS EXPECTED WITH THE ALTERNATIVE PLATE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: DRILL GUIDE (PAR# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), DRILL BIT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), BUTTRESS PIN (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) . THIS REPORT IS FOR ONE (1) 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/3H SHAFT/LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4)

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7286226 ↗
• MalfunctionNov 9, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING REPAIR OF THE DISTAL RADIUS ON (B)(6) 2017, THE SURGEON WENT TO AFFIX THE DISTAL RADIUS PLATE WITH THE FIRST SCREW IN ONE OF THE LOCKING HOLES AND THE SCREW WOULD NOT LOCK IN OR SEAT TO THE PLATE AS EXPECTED. THE PLATE AND SCREW WERE REMOVED FROM THE PATIENT AND A BACKUP PLATE AND SCREW AVAILABLE (POSSIBLY THE SAME PART NUMBERS) IN THE SET WERE IMPLANTED IN THE PATIENT WITHOUT ISSUE. THERE WAS A FIVE-MINUTE DELAY AS THE BACKUP DEVICES WERE RETRIEVED FROM THE READILY AVAILABLE SET. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH PATIENT IN STABLE CONDITION. UPON INSPECTION OF THE DEVICES, THE REPORTER STATED THAT ONE OF THE HOLES IN THE PLATE LOOKS AS THOUGH IT WAS NOT MACHINED PROPERLY. HE FURTHER EXPLAINED THAT ONE OF THE FOUR HOLES ON THE VARIABLE ANGLE PLATE HAS THREADS THAT ARE MALFORMED OR "MESSED UP". CONCOMITANT DEVICES REPORTED: SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.4 MM DISTAL RADIUS PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7013938 ↗
• MalfunctionMay 11, 2017Fitting Problem; Component Missing; Fitting Problem; Component Missing

  IT WAS REPORTED THAT THE 2.4 VARIABLE ANGLE LOCKING SCREWS WOULD NOT LOCK INTO THE 2.4MM VARIABLE ANGLE- LOCKING COMPRESSION PLATE (VA-LCP) DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT DISTAL RADIUS ON (B)(6) 2017. THE TWO TOP LEFT HOLES OF THE PLATE LOOK LIKE THERE ARE NO THREADS AND WOULD NOT LOCK THE SCREWS. THE SURGEON USED ANOTHER PLATE (PROBABLY NOT SYNTHES) TO COMPLETE THE SURGERY. IT APPEARS ANOTHER SCREW WAS USED TO COMPLETE THE SURGERY. PATIENT STATUS AND SURGICAL DELAY ARE UNKNOWN. IT IS ALSO UNKNOWN WHETHER THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: 2.4 VARIABLE ANGLE LOCKING SCREWS (PART# 02.210.120, LOT# UNKNOWN, QUANTITY UNKNOWN). (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6562390 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083694. One submission often covers many models, so check the product and lot details in each record.

• Z-2087-2013 · Jul 30, 2013 · Terminated
  Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the dista
• Z-2057-2013 · May 31, 2013 · Terminated
  Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and