NA 212.114Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982151889), received between Apr 18, 2019 and Mar 20, 2020 — classified as 1 injury, 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); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT FELL RESULTING IN A DISPLACED RIGHT PROXIMAL HUMERUS FRACTURE. ON (B)(6) 2009, THE PATIENT UNDERWENT AN OPEN TREATMENT OF RIGHT PROXIMAL HUMERUS FRACTURE WITH TUBEROSITY REPAIR. PLATE AND SCREWS WERE IMPLANTED. AFTER THE PROCEDURE, THE PATIENT WAS EXPERIENCING MEDICAL DEVICE SITE REACTION AND WAS DEALING WITH IT FOR 5 YEARS. THE PATIENT WANTED THE PLATE AND SCREWS TO BE REMOVED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SELF TAPPING WITH STARDRIVE RECESS 35MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). THIS COMPLAINT INVOLVES TOTAL 11 DEVICES, REMAINING 10 DEVICES ARE CAPTURED UNDER RELATED COMPLAINT.

  Patient problems: Reaction

  MAUDE report 9859934 ↗
• 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) 3.5 MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 35 MM THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527120 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684. 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,