VA-LCP 02.107.304Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982029355), received between Dec 4, 2017 and Sep 25, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K120070); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Device-Device Incompatibility

  It was reported that there was rust on items. The items are not able to be sterilized. The Locking holes in plates are compromised / did not lock in surgeries. There was no patient harm or surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900141 ↗
• MalfunctionSep 25, 2026Device-Device Incompatibility

  It was reported that the Locking holes in plates are compromised / did not lock in surgeries. There is no surgical delay or patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898294 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION WITH PLATES AND SCREWS AND COMPRESSION DUE TO NONUNION LEFT PROXIMAL ULNA S/P ORIF MONTEGGIA FRACTURE SUBLUXATION. ON (B)(6) 2017, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF THE COMMINUTED LEFT PROXIMAL ULNA AND WHERE A SYNTHES DEVICE WAS IMPLANTED. PRIOR TO THE REPORTED EVENT, THE PATIENT TRIPPED OVER A CURB AND FELL HER ON HER LEFT UPPER EXTREMITY RESULTING TO AN IMMEDIATE SEVERE PAIN. CONCOMITANT DEVICES REPORTED: 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 24MM (PART NUMBER 201.374.97, LOT UNKNOWN, QUANTITY 1), 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18MM (PART NUMBER 212.105, LOT UNKNOWN, QUANTITY 1), 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/28MM (PART NUMBER 02.118.528, LOT UNKNOWN, QUANTITY 1), 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/34MM (PART NUMBER 02.118.534, LOT UNKNOWN, QUANTITY 1), 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM (PART NUMBER 02.211.020, LOT UNKNOWN, QUANTITY 2), 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 22MM (PART NUMBER 02.211.022, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 10444420 ↗
• InjuryAug 24, 2020Adverse 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 A HARDWARE REMOVAL DUE TO LEFT ELBOW MONTEGGIA FRACTURE DISLOCATION WITH ULNAR NONUNION, STATUS POST BONE GRAFTING WITH NOW PAINFUL DEEP HARDWARE, POSSIBLE DELAYED UNION, AS WELL AS ULNAR NERVE COMPRESSION. ON (B)(6) 2017, THE PATIENT UNDERWENT A SURGERY AND WAS DIAGNOSED WITH NONUNION LEFT PROXIMAL ULNA STATUS POST OPEN REDUCTION INTERNAL FIXATION MONTEGGIA FRACTURE SUBLUXATION AND WAS IMPLANTED WITH A SYNTHES PLATE AND SCREWS. CONCOMITANT DEVICES REPORTED: 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/28MM (PART NUMBER 02.118.528, LOT UNKNOWN, QUANTITY 1), 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM (PART NUMBER 02.211.024, LOT UNKNOWN, QUANTITY 1), 2.7MM VA LCK SCREW SLF-TAP (PART NUMBER 02.211.036, LOT UNKNOWN, QUANTITY 1), 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 40MM (PART NUMBER 02.211.040, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/LT/116MM. THIS IS REPORT 1 OF 5 FOR (B)(4). THIS PRODUCT (B)(4), CAPTURES THE REMAINING FIVE (5) OUT OF FIFTEEN (15) DEVICES. (B)(4) CAPTURES THE FIRST TEN (10) DEVICES OF THE THIRD REVISION. (B)(4) CAPTURES

  Patient problems: Nerve Damage; No Code Available; Pain

  MAUDE report 10441862 ↗
• MalfunctionJun 14, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION OF OLECRANON AND RADIAL HEAD, AND OLECRANON PLATE IMPLANTATION ON (B)(6) 2018. THE 4 HOLE 2.7/3.5 VA OLECRANON PLATE WAS IMPLANTED AND THE TWO LOCKING SCREWS HOLES WERE LEFT EMPTY. DURING THE PROCEDURE TWO OF THE LOCKING HOLES IN THE PLATE DID NOT ALLOW THE (2) UNKNOWN LOCKING SCREWS TO ENGAGE AND WOULD NOT LOCKDOWN INTO THE PLATE, AND WITH PRESSURE USED TO TRY AND INSERT THE SCREW, THE HOLES BEGAN TO STRIP THE THREADS OF THE SCREW. IT WAS NOTED THAT UNKNOWN CORTEX SCREW AND UNKNOWN LOCKING SCREW WERE USED TO ATTACHED THE PLATE. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: CORTEX SCREW (PART 202.XXX, LOT UNKNOWN, QUANTITY UNKNOWN); LOCKING SCREW (PART 02.211.XXX, LOT UNKNOWN, QUANTITY UNKNOWN) THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7603128 ↗
• InjuryDec 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL OF AN OLECRANON PLATE CONSTRUCT ON (B)(6) 2017 DUE TO INFECTION. THE PATIENT HAD PRESENTED TO OPERATING ROOM (OR) ON (B)(6) 2017 FOR A GRADE 2 OPEN COMMINUTED OLECRANON FRACTURE AND A MEDIAL EPICONDYLE AVULSION. ALL REMOVED HARDWARE WAS INTACT. THE DISTAL HUMERUS HARDWARE REMAINS IMPLANTED. THE SURGEON STATED THAT THE INFECTION WAS MOST LIKELY DUE TO AN OPEN WOUND AND PATIENT HYGIENE ISSUES. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADDITIONAL MEDICAL INTERVENTION. PATIENT WAS LISTED AS STABLE POST-OPERATIVELY. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7125318 ↗
• InjuryDec 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL ON (B)(6) 2017 DUE TO THE ARTICULAR SURFACE OF THE PROXIMAL METAPHYSEAL BONE OF THE ULNA COLLAPSING AROUND THE PLATE AND SCREWS CONSTRUCT LEADING TO INTRA-ARTICULAR PENETRATION AND A MALUNION. THE ORIGINAL CONSTRUCT INCLUDED ONE (1) VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) OLECRANON PLATE, THREE (3) 3.5 MM SELF-TAPPING CORTEX SCREWS, THREE (3) 2.7 MM VA LOCKING SCREWS AND ONE (1) 2.7 MM METAPHYSEAL INDEPENDENT LAG SCREW THAT LEAD TO THE THREE (3) 2.7 MM VA LOCKING SCREWS. THE INITIAL SURGERY TO IMPLANT THE PLATE AND SCREW CONSTRUCT WAS CONDUCTED ON AN UNKNOWN DATE. SUBSEQUENTLY, THE ARTICULAR SURFACE OF THE BONE COLLAPSED CAUSING PAIN TO THE PATIENT, AND THUS LED TO THE ENTIRE PLATE AND SCREWS CONSTRUCT TO BE REMOVED. ALL HARDWARE WAS REMOVED INTACT AND AS PER THE SURGEON, THE HARDWARE NOT BROKEN, DAMAGED OR DEFICIENT UPON REMOVAL. IT WAS ALSO REPORTED THAT A SYNTHES RADIAL HEAD CONSTRUCT WAS ALSO INITIALLY IMPLANTED IN THE VICINITY OF THE PLATE AND SCREWS CONSTRUCT ON AN UNKNOWN DATE AND THE SURGEON DID NOT REMOVE IT SINCE HE BELIEVED THAT THE RADIAL HEAD PROSTHESIS DID NOT CONTRIBUTE TO THE EVENT. NO ADDITIONA

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 7079238 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120070. One submission often covers many models, so check the product and lot details in each record.

• Z-0124-2016 · Sep 28, 2015 · Terminated
  Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes