VA-LCP 02.112.048Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982033055), received between Jan 13, 2021 and Sep 21, 2021 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A FRACTURE FIXATION FOR A SHAFT FRACTURE UTILIZING A VA-LCP ANTERIOR PLATE. THERE WAS A UNION OF FRACTURE AFTER 6 WEEKS DURATION AND THERE WERE POST-OPERATIVE COMPLICATIONS REPORTED, WHICH IS THE PATIENT EXPERIENCED DISTAL NUMBNESS AND LIMITED RANGE OF MOTION. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.7/3.5 VA-LCP LAT ANT CLAV PL/11H/113. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Loss of Range of Motion; Numbness

  MAUDE report 12507420 ↗
• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A FRACTURE FIXATION FOR A SHAFT FRACTURE UTILIZING A VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) ANTERIOR PLATE. THERE WAS A UNION OF FRACTURE AFTER 8 WEEKS DURATION AND THERE WAS POST-OPERATIVE COMPLICATION REPORTED, WHICH IS THE PATIENT EXPERIENCED A "BUMP" OVER LATERAL CLAVICLE. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/11H/113MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12506903 ↗
• InjurySep 21, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FIXATION OF A SHAFT FRACTURE UTILIZING A VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) ANTERIOR PLATE. THERE WERE INTRA-OPERATIVE COMPLICATIONS REPORTED, WHICH PATIENT EXPERIENCED WITH A PREVIOUS SUPERIOR PLATE FIXATION WHICH FAILED (NOT LISTED IN THIS STUDY). HARDWARE REMOVAL DONE AND BONE GRAFT/GRAFTON PASTE USED FOR REVISION SURGERY. THERE WAS A UNION OF FRACTURE AFTER 16 WEEKS DURATION. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/11H/113MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12506819 ↗
• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A FRACTURE FIXATION FOR A SHAFT FRACTURE UTILIZING A VA-LCP ANTERIOR PLATE. POSTOPERATIVELY, THE PATIENT HAD DECREASED RANGE OF MOTION, PAIN WITH RANGE OF MOTION. THERE WAS A UNION OF FRACTURE AFTER 6 WEEKS DURATION. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7/3.5 VA-LCP LAT ANT CLAV PL/11H/113. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 12506720 ↗
• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A FRACTURE FIXATION FOR A SHAFT FRACTURE UTILIZING A VA-LCP ANTERIOR PLATE. POSTOPERATIVELY, THE PATIENT EXPERIENCED SUTURE ABSCESS WHICH WAS RESOLVED. THERE WAS A FRACTURE UNION AFTER AN 8 WEEK DURATION. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7/3.5 VA-LCP LAT ANT CLAV PL/11H/113. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Abscess

  MAUDE report 12506243 ↗
• InjurySep 20, 2021Break; Break

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A FRACTURE FIXATION FOR A SHAFT FRACTURE UTILIZING A VA-LCP ANTERIOR PLATE. PATIENT HAD ADDITIONAL INJURY ONE(1) YEAR POST INITIAL SURGERY AND UNDERWENT REOPERATION FOR RE-FIXATION. THERE WAS A UNION OF FRACTURE FOR ABOUT 6 WEEKS DURATION. CONCOMITANT DEVICES REPORTED: UNK - SCREWS: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 9). THIS REPORT IS FOR ONE (1) 2.7/3.5 VA-LCP LAT ANT CLAV PL/11H/113. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12502518 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A FRACTURE FIXATION FOR A SHAFT FRACTURE UTILIZING VA-LCP ANTERIOR PLATE. PLATE LCP 7 HOLE 2.0 X 52MM, SUPERIOR PLACEMENT- FRACTURE FIXATION WAS AN ADDED SURGICAL INTERVENTION. EXTENDED ICU STAY, RECURRENT SHOULDER DISCOMFORT REPORTED POST-OPERATIVELY. UNION WAS ACHIEVED AFTER 6 WEEKS. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: CORTEX: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ELEVEN (11) DEVICES. THIS REPORT IS FOR (1)1.5MM DRILL BIT/QC/110MM. THIS REPORT IS 1 OF 11 FOR (B)(4).

  Patient problems: Discomfort

  MAUDE report 12492320 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A PROCEDURE FOR A SHAFT FRACTURE FIXATION UTILIZING VA-LCP ANTERIOR PLATE. PATIENT HAD A INCREASED PAIN IMMEDIATELY POSTOPERATIVELY, WHICH WAS RESOLVED BY POSTOP WEEK 2. UNION WAS ACHIEVED AFTER 8 WEEKS. NO POST-OPERATIVE COMPLICATIONS REPORTED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR (1) 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/11H/113MM CLOSE. THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12491958 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A FRACTURE FIXATION FOR A SHAFT FRACTURE UTILIZING VA-LCP ANTERIOR PLATE. DECREASED INTERNAL ROTATION, PAIN/IMPINGEMENT LATERALLY REPORTED POST-OPERATIVE. REOPERATION WAS PERFORMED DUE TO HARDWARE REMOVAL 1 YEAR POSTOPERATIVELY, PATIENT COULD FEEL IMPLANT. UNION WAS ACHIEVED AFTER 6 WEEKS. PATIENT IS DUE FOR DPS IMPLANTS. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 9). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/11H/113MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Nerve Damage; Pain; Skin Inflammation/ Irritation

  MAUDE report 12491754 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A NONUNION, LATERAL FRACTURE. VA-LCP ANTERIOR PLATE WAS USED. THERE WAS A REOPERATION DUE TO DPS IMPLANTS AND HARDWARE REMOVAL, PATIENT COULD FEEL IMPLANT. UNION WAS ACHIEVED AFTER 6 WEEKS. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES 1 (ONE) DEVICE. THIS REPORT IS FOR (1)1.5MM DRILL BIT/QC/110MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12484752 ↗
• MalfunctionSep 3, 2021Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A FRACTURE FIXATION FOR A SHAFT FRACTURE UTILIZING A VA-LCP ANTERIOR PLATE. THERE WAS A UNION OF FRACTURE AFTER 6 WEEKS DURATION AND THERE WERE INTRA-OPERATIVE COMPLICATIONS REPORTED, WHICH IS THE PATIENT EXPERIENCED OVER-COUNTOURING OF PLATE, LOCKING HOLE DID NOT LOCK AND DIFFICULTY BACKING SCREW OUT. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/11H/113MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12423999 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN SURGERY, LOCKING COMPRESSION PLATE, CORTEX SCREWS, AND LOCKING SCREWS WERE TAKEN OUT DUE TO PATIENT PAIN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: 2.7MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 202.816, LOT UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.816, LOT UNKNOWN, QUANTITY 1); 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM (PART NUMBER 212.104, LOT UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW SELF-TAPPING 14MM (PART NUMBER 204.814, LOT UNKNOWN, QUANTITY 1); 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART NUMBER 02.211.016, LOT UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.816, LOT UNKNOWN, QUANTITY 1); 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART NUMBER 02.211.016, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/11H/113MM. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11163182 ↗