NA 212.106Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982151803), received between Feb 5, 2018 and Sep 6, 2019 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

1 other recall cover devices cleared under the same FDA submission (K000684, K072095); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN (B)(6) 2018 THE PATIENT UNDERWENT A REMOVAL SURGERY TO REMOVE THE SYNTHES OLECRANON PLATE DUE TO PAIN AND SYMPTOMATIC HARDWARE. ON (B)(6) 2016, THE PATIENT WAS ASSEMBLING A PARADE FLOAT WHERE SHE WAS KNOCKED OFF BY AN OBJECT AND FELL 5 FEET TO THE GROUND. SHE FELL ON OUTSTRETCHED HANDS AND THEN ONTO HER FACE. SHE REPORTS SIGNIFICANT AMOUNT OF PAIN IN BILATERAL UPPER EXTREMITIES AND LEFT SIDE OF FACE. SHE SUFFERED AN ELBOW FRACTURE THAT REQUIRED SURGERY AND THE PLACEMENT OF A SYNTHES RADIAL HEAD PROSTHESIS SYSTEM IN HER LEFT ELBOW AND SYNTHES OLECRANON LOCKING PLATE AND SCREWS IN HER RIGHT ELBOW. ON (B)(6) 2018, THE PATIENT UNDERWENT REMOVAL HARDWARE. MULTIPLE STAB WOUNDS WERE MADE ALONG THE COURSE OF THE OLECRANON PLATE AND THE SCREWS WERE REMOVED. ONCE THE SCREWS WERE REMOVED FROM THE OLECRANON PLATE, WE WERE ABLE TO PASS IN AN ELEVATOR AND LOOSEN THE PLATE OFF THE BACK OF THE OLECRANON. THE PLATE WAS THEN FED OUT THROUGH ONE OF THE INCISIONS AND WE WERE ABLE TO REMOVE THE WHOLE PLATE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS ONE (1) 3.5 MM LOCKING SCREW SLF-TPNG W/STAR DRIVE(TM) RECESS 20 MM. THIS REPORT IS 6 OF 6 FOR (B)(4).

  Patient problems: Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8972546 ↗
• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 THE PATIENT UNDERWENT A REMOVAL SURGERY TO REMOVE THE SYNTHES OLECRANON PLATE DUE TO PAIN AND SYMPTOMATIC HARDWARE. ON (B)(6) 2016, THE PATIENT WAS ASSEMBLING A PARADE FLOAT WHERE SHE WAS KNOCKED OFF BY AN OBJECT AND FELL 5 FEET TO THE GROUND. SHE FELL ON OUTSTRETCHED HANDS AND THEN ONTO HER FACE. SHE REPORTS SIGNIFICANT AMOUNT OF PAIN IN BILATERAL UPPER EXTREMITIES AND LEFT SIDE OF FACE. SHE SUFFERED AN ELBOW FRACTURE THAT REQUIRED SURGERY AND THE PLACEMENT OF A SYNTHES RADIAL HEAD PROSTHESIS SYSTEM IN HER LEFT ELBOW AND SYNTHES OLECRANON LOCKING PLATE AND SCREWS IN HER RIGHT ELBOW. ON (B)(6) 2018, THE PATIENT UNDERWENT REMOVAL HARDWARE. MULTIPLE STAB WOUNDS WERE MADE ALONG THE COURSE OF THE OLECRANON PLATE AND THE SCREWS WERE REMOVED. ONCE THE SCREWS WERE REMOVED FROM THE OLECRANON PLATE, WE WERE ABLE TO PASS IN AN ELEVATOR AND LOOSEN THE PLATE OFF THE BACK OF THE OLECRANON. THE PLATE WAS THEN FED OUT THROUGH ONE OF THE INCISIONS AND WE WERE ABLE TO REMOVE THE WHOLE PLATE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS ONE (1) 3.5 MM LOCKING SCREW SLF-TPNG W/STAR DRIVE(TM) RECESS 20 MM THIS REPORT IS 5 OF 6 FOR (B)(4).

  Patient problems: Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8972542 ↗
• InjuryJun 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT UNDERWENT A REMOVAL PROCEDURE OF PAINFUL HARDWARE PROXIMAL ASPECT OF RIGHT ULNA. ON (B)(6) 2014, THE PATIENT SUSTAINED AN INJURY AFTER TRIPPING AND FALLING FROM A STANDING POSITION AND LANDED DIRECTLY INTO THE RIGHT ELBOW. THE PATIENT HAD THE ONSET OF PAIN AND INABILITY TO FULLY USE THE ELBOW. SUBSEQUENT X-RAYS WERE TAKEN AND REVEALED A DISPLACED, DISTRACTED OLECRANON FRACTURE, WITH A COMMINUTED RIGHT RADIAL HEAD FRACTURE. THE PATIENT ALSO COMPLAINS OF PAIN IN THE RIGHT PROXIMAL HUMERUS. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2014 WITH ONE (1) VARIABLE ANGLE ¿ LOCKING COMPRESSION PLATE (VA-LCP) PROXIMAL, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 20MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 24MM, 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, ONE (1) LOCKING SCREW SELF-TAPPING WITH STARD

  Patient problems: Bone Fracture(s); Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8692658 ↗
• MalfunctionApr 18, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HUMERUS FRACTURE PROCEDURE. DURING THE PROCEDURE, THE DOCTOR TRIED TO USE A THIRD BARREL PLATE AND COULD NOT BECAUSE ONE (1) CORTEX SCREW, ONE (1) CANCELLOUS SCREW AND ONE (1) LOCKING SCREW WERE NOT THREADING ON THE PLATE. THEY MENTIONED TO CHANGED THE PLATE, BUT THE DOCTOR FURIOUSLY TOOK THE PLATE AND WENT TO TEST IT, BUT THE PLATE WAS NOT THE PROBLEM. THE PROBLEM WAS WITH THE SCREWS THAT HAD THE THREADED DUSTED. THE THIRD BARREL PLATE WAS NOT PLACED IN THE PATIENT BECAUSE THE PATIENT'S BONE WAS VERY POROUS. THE DOCTOR PLACE THE PHILOS PLATE SINCE IT WAS SUFFICIENT TO REDUCE THE FRACTURE. THERE WAS A THIRTY (30) MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NOT INJURED AND WAS DOING VERY WELL. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1) THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 20MM THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527119 ↗
• InjuryFeb 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT PROCEDURE FOR OSTEOSYNTHESIS DISTAL TIBIA AND RIGHT FIBULA. REPORTEDLY, LCP 3.5 MM PLATES FOR DISTAL TIBIA IN TITANIUM AND STEEL WITH THEIR RESPECTIVE SCREW RACKS WERE SENT FOR THIS PROCEDURE. THE TIBIAL OSTEOSYNTHESIS PROCEDURE WAS STARTED WITH A VERY DISTAL FRACTURE. A 6-HOLE RIGHT MEDIAL PLATE WAS PLACED IN TITANIUM AND FIXATION WAS STARTED IN THE DISTAL PART. THE DOCTOR NEEDED A BLOCKED SCREW OF 3.5 MM OF 14 MM BUT THE SCREWS IN TITANIUM RACK STARTED FROM 26 MM UP TO 60 MM IN LENGTH; THE DOCTOR WAS UPSET AND PLACED A 3.5 MM X 14 MM LOCKED SCREW IN STEEL, SINCE STEEL SCREWS COME FROM 10 MM TO 60 MM IN LENGTH. FIXATION WAS CONTINUED AND IN THE BODY OF THE PLATE THE DOCTOR DECIDED TO PLACE A BLOCKED SCREW OF 3.5 MM X 20 MM, BUT AGAIN A SCREW LOCKED OF 3.5 MM X 20 MM IN STEEL WAS PLACED DUE TO THE MISSING TITANIUM SCREW OF 3.5 MM X 20 MM LENGTH IN THE TITANIUM SCREW RACK. FIXATION OF THE FIBULA WAS PERFORMED WITHOUT PROBLEMS. BECAUSE OF THIS EVENT, THE DOCTOR WAS UPSET AND MADE THE OBSERVATION OF THE CONFLICT OF MATERIALS THAT CAN PRODUCE METALLOSIS. CONCO

  Patient problems: Foreign Body In Patient

  MAUDE report 7241118 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684, K072095. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,