NEOVIEW® W27 ST014Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03760225713594), received between Nov 10, 2016 and Jul 12, 2017 — classified as 2 malfunctions.

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

4 other recalls cover devices cleared under the same FDA submission (K160995); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2017Device Issue; Device Operates Differently Than Expected; Device Issue; Device Operates Differently Than Expected

  IT HAS BEEN REPORTED BY OUR DISTRIBUTOR IN (B)(6) ON (B)(6) 2017: "SURGERY OF A DISTAL RADIUS FRACTURE, WITH NEOVIEW VOLAR PLATE, REF. P30 SP210. THE FIRST INTERVENTION HAS BEEN PERFORMED WITH THIS PLATE ON A RELATIVELY SIMPLE FRACTURE. THE OPERATIVE TECHNIQUE HAS BEEN FOLLOWED AS INDICATED IN THE BROCHURE. IN THE BEGINNING THE FIRST SCREW HAS BEEN POSITIONED IN THE OBLONG PROXIMAL HOLE OF THE PLATE, THEN ALL THE OTHER DISTAL SCREWS. DURING THE FLUOROSCOPY CHECK THE SURGEON DECIDED TO CHANGE THE MEASURE OF THE SCREW IN THE OBLONG HOLE (14MM), BECAUSE HE ASSESSED IT WAS TOO LONG. SO HE STARTED WITH THE REMOVAL OF THE INSERTED SCREW REF. W27 ST014. AS HE ENGAGED THE SCREW AND TURNED THE DRIVER BACKWARD TO REMOVE IT, THE SCREW-HEAD BROKE UP, LEAVING THE SCREWED STEM INTO THE BONE. NO STRENGTH HAS BEEN REQUIRED FOR THIS TO OCCUR AND THE FIRST SCREW WAS NOT EVEN TIGHTENED TOTALLY AS RECOMMENDED IN THE TECHNIQUE. THE SURGEON TRIED TO REMOVE THE STEM WITH A NON-INVASIVE APPROACH, BUT WITHOUT ANY SUCCESS. SO HE DECIDED TO LEAVE THE STEM INTO THE BONE TO PREVENT ANY FURTHER DAMAGE FOR THE PATIENT." PATIENT OUTCOME REPORTED BY OUR DISTRIBUTOR: "- SIGNIFICANT INCREASE OF THE SURGERY TIME : AD

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6706250 ↗
• MalfunctionNov 10, 2016Improper or Incorrect Procedure or Method; Device Issue; Improper or Incorrect Procedure or Method; Device Issue

  WRIST SURGERY: THE NEOVIEW PLATE-SCREW SYSTEM IS INDICATED FOR FIXATION OF INTRA-ARTICULAR AND EXTRA-ARTICULAR FRACTURES OF THE DISTAL RADIUS AND RECONSTRUCTION OF THE DISTAL RADIUS. IT HAS BEEN REPORTED TO IN2BONES THAT 2 NON-LOCKING SCREWS BROKE WHEN BEING INSERTED DURING THE FIXATION OF THE PROXIMAL PART OF THE PLATE. EACH SCREW BODY REMAIN IN THE PATIENT AND 2 ADDITIONAL SCREWS HAVE BEEN IMPLANTED TO SECURE THE FIXATION OF THE PROXIMAL PART OF THE SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6092815 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160995. One submission often covers many models, so check the product and lot details in each record.

• Z-2869-2017 · Jul 13, 2017 · Terminated
  Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.27 - 12 mm, REF W27 ST012 (d) NEO(R) 0.27 - 14
• Z-0953-2017 · Dec 19, 2016 · Terminated
  NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW Plating System is intended for fixation of intra-articular and ext
• Z-0954-2017 · Dec 19, 2016 · Terminated
  NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and recons
• Z-0952-2017 · Dec 19, 2016 · Terminated
  SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW Plating System is intended for fixation of intra-arti