NA 02.211.050Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982053763), received between Sep 28, 2018 and Jan 6, 2023 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT THE DEVICES IN 2016. THE PATIENT FOUND OUT THAT THERE WAS A PROBLEM WITH THE IMPLANTS APPROXIMATELY 2 MONTHS AGO WHEN HE WENT TO THE ER BECAUSE HIS ARM WAS BAD, AND X-RAYS WERE TAKEN. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE HARDWARE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 50MM. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16113700 ↗
• InjuryJul 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022 THERE WAS LACK OF LOCKING OF 2.7 MM LOCKING SCREWS IN TWO (2) LOW COMPRESSION PLATE (LCP) ELBOW PLATES WITH A DYNAMOMETRIC SCREWDRIVER INTRAOPERATIVELY. SEVERAL SCREWS BENT AND THERE WERE TWO (2) EDGES ON ONE SIDE. THE PATIENT WAS IMMOBILIZED FOR TEN (10) DAYS AND X-RAYS WERE TAKEN. A SURGICAL REVISION IS PLANNED TO REMOVE EVERYTHING BUT HAS NOT YET BEEN COMPLETED. IMPLANTS ARE STILL CURRENTLY IMPLANTED IN THE PATIENT. THIS IS REPORT 10 OF 12 FOR (B)(4). THIS REPORT IS FOR A LOCKING SCREW.

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

  MAUDE report 15074217 ↗
• InjuryJul 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022 THERE WAS LACK OF LOCKING OF 2.7 MM LOCKING SCREWS IN TWO (2) LOW COMPRESSION PLATE (LCP) ELBOW PLATES WITH A DYNAMOMETRIC SCREWDRIVER INTRAOPERATIVELY. SEVERAL SCREWS BENT AND THERE WERE TWO (2) EDGES ON ONE SIDE. THE PATIENT WAS IMMOBILIZED FOR TEN (10) DAYS AND X-RAYS WERE TAKEN. A SURGICAL REVISION IS PLANNED TO REMOVE EVERYTHING BUT HAS NOT YET BEEN COMPLETED. IMPLANTS ARE STILL CURRENTLY IMPLANTED IN THE PATIENT. THIS IS REPORT 8 OF 12 FOR PC-(B)(4). THIS REPORT IS FOR A LOCKING SCREW.

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

  MAUDE report 15073968 ↗
• MalfunctionJul 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) PROCEDURE. A TWO-HOLE VA-LCP PROXIMAL TIBIA PLATE SYSTEM WERE USED. UPON SURGERY FOUR (4) VA LOCKING SCREWS WERE INSERTED TO THE PLATE. ONE (1) LOCKING SCREW WAS SWAPPED OUT DUE TO IT DIDN'T LOCK INTO THE PLATE. THE THREE (3) VA LOCKING SCREWS WERE LEFT IN THE PLATE. THERE WAS A ONE-MINUTE SURGICAL DELAY. PATIENT OUTCOME WAS SUCCESSFUL. CONCOMITANT DEVICES REPORTED: VA-LCP OLECR PL 2.7/3.5 LE 2HO L90 SST (PART# 02.107.302, LOT# UNKNOWN, QUANTITY# 1); 2.7MM VA LCK SCREW SLF-TAP (PART# 02.211.012, LOT# UNKNOWN, QUANTITY# 1); 2.7MM VA LCK SCREW SLF-TAP (PART# 02.211.014, LOT# UNKNOWN, QUANTITY# 1); 2.7MM VA LCK SCREW SLF-TAP (PART# 02.211.048, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1)2.7MM VA LCK SCREW SLF-TAP. THIS REPORT IS 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214505 ↗
• MalfunctionFeb 13, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE WHILE THE SURGEON WAS PUTTING THE VARIABLE ANGLE LOCKING SCREW IN THE THREAD OF THE SCREWS CAME APART. THE VARIABLE ANGLE LOCKING SCREW WAS TAKEN OUT BEFORE ANY FURTHER DAMAGE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT STATUS AND PROCEDURE OUTCOMES ARE UNKNOWN. CONCOMITANT DEVICES: UNKNOWN INSERTION INSTRUMENTS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9708290 ↗
• InjuryJun 10, 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 50MM, ONE (1) CORTEX SCREW SELF-TAPPING 20MM, ONE (1) CORTEX SCREW SELF-TAPPING 24MM, THREE (3) CORTEX SCREWS SELF-TAPPING 20MM, ONE (1) CORTEX SCREW SELF-TAPPING 22MM, ONE (1) CORTEX SCREW SELF-TAPPING 26MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, ONE VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 22MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 30MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 40MM AND ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 50MM. 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 COMPLETED. P

  Patient problems: Pain

  MAUDE report 8684367 ↗
• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT HAD UNDERGONE AN ORTHOPEDIC REMOVAL PROCEDURE DUE TO PAIN. ORIGINAL DATE OF IMPLANT WAS ON (B)(6) 2012 FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT ELBOW. IT WAS NOTED THAT FRACTURE HAD ALREADY HEALED. DEVICES INVOLVED WERE ONE (1) 3.5 MM CORTEX SCREW 16MM, ONE (1) 3.5MM CORTEX SCREW 20MM, ONE (1) 3.5 MM CORTEX SCREW 24MM, ONE (1) 3.5MM CORTEX SCREW 26MM, ONE (1) VARIABLE ANGLE (VA)-LOCKING COMPRESSION PLATE (LCP) EXTENDED MEDIAL DISTAL HUMERUS PLATE, ONE (1) METAPHYSEAL SCREW, ONE (1) 2.7MM VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 50MM, TWO (2) 2.7MM VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 60MM, ONE (1) LCP POSTEROLATERAL DISTAL HEMERUS PLATE WITH LATERAL SUPPORT, ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, TWO (2) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 20MM, AND ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 60MM. ALL IMPLANTS WERE REMOVED EXCEPT FOR FOUR (4) SCREWS AS THE HEADS OF THE SCREWS WERE BROKEN OFF. IT WAS NOT DETERMINED WHICH AMONG THE SCREWS WERE

  Patient problems: Pain

  MAUDE report 8245278 ↗
• InjuryDec 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018, DUE TO A NONUNION AND HARDWARE FAILURE. PATIENT INITIALLY HAD AN OPEN REDUCTION AND INTERNAL FIXATION SURGERY ON (B)(6) 2018, TO TREAT A LEFT DISTAL HUMERUS FRACTURE. THE IMPLANTED DEVICES WERE VARIABLE ANGLE DISTAL HUMERUS PLATE, VARIABLE ANGLE-LCP LAT DISTAL HUMERUS PLATE, EIGHT (8) VARIABLE ANGLE LOCKING SCREW SELF-TPING WITH T8 STARDRIVE, VARIABLE ANGLE LOCKING SCREW SELF-TPING WITH T8 STARDRIVE, VARIABLE ANGLE-LCP PROXIMAL OLECRANON, AND FOUR (4) ORTEX SCREW SELF- TAPPING. THE PROCEDURE WAS COMPLETED, AND ALL HARDWARE WAS REMOVED INTACT. THE FRACTURE WAS REDUCED, AND AN UNKNOWN VARIABLE ANGLE ELBOW PLATE WITH UNKNOWN SCREWS WERE USED FOR FIXATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS STABLE. THIS REPORT IS FOR ONE (1) 2.7 MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 50 MM THIS IS REPORT 8 OF 10 FOR (B)(4). DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT IS A CONTINUATION FROM COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 8129464 ↗
• MalfunctionSep 28, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2018 A 2.7MM VARIABLE ANGLE LOCKING SELF-TAPPING SCREW WAS NOTED AS BENT. THIS WAS DETERMINED DURING A ROUTINE INCOMING INSPECTION. THIS COMPLAINT DOES NOT INVOLVE A PATIENT OR A PROCEDURE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7920819 ↗