NA 1896-4024SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540202307), received between Sep 15, 2021 and Sep 3, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Biocompatibility” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2025Biocompatibility; Biocompatibility

  CUSTOMER SERVICE WAS CONTACTED BY A PATIENT INFORMING SHE HAS BEEN SUFFERING FROM SEVERE SKIN RASHES AND PAIN AFTER AN IMPLANT EMERGENCY SURGERY IN THE UPPER ARM AND REQUESTS SAMPLE OF THE COMPOSITION (METALS ETC) OF THE IMPLANTS AND SCREWS AS WELL AS A SAMPLE OF THE IMPLANTS SO THAT THE LAB/DERMATOLOGIST CAN DETERMINE WHETHER THE PARTS NEED TO BE REMOVED OR WHETHER THERE IS ANOTHER SOLUTION.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 22950345 ↗
• InjurySep 3, 2025Biocompatibility; Biocompatibility

  CUSTOMER SERVICE WAS CONTACTED BY A PATIENT INFORMING SHE HAS BEEN SUFFERING FROM SEVERE SKIN RASHES AND PAIN AFTER AN IMPLANT EMERGENCY SURGERY IN THE UPPER ARM AND REQUESTS SAMPLE OF THE COMPOSITION (METALS ETC) OF THE IMPLANTS AND SCREWS AS WELL AS A SAMPLE OF THE IMPLANTS SO THAT THE LAB/DERMATOLOGIST CAN DETERMINE WHETHER THE PARTS NEED TO BE REMOVED OR WHETHER THERE IS ANOTHER SOLUTION.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 22950344 ↗
• InjuryJun 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ¿DEPARTMENT OF ORTHOPAEDIC HAND AND MICROSURGERY CENTER, OSAKA EKISAIKAI HOSPITAL, JAPAN¿. THE TITLE OF THIS REPORT IS, ¿EVALUATION OF INTRAMEDULLARY NAIL FIXATION VIA THE NEVIASER PORTAL FOR PROXIMAL HUMERUS FRACTURE¿ PUBLISHED ON FEBRUARY 08, 2019, WHICH IS ASSOCIATED WITH THE STRYKER ¿T2 PROXIMAL HUMERAL NAILING SYSTEM¿. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1016/J.JCOT.2019.02.007. THIS REPORT INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 4 PATIENTS. THE CASES IN THIS STUDY RANGE FROM APRIL 2014 AND MARCH 2017. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. IT WAS REPORTED THAT 1 PATIENT EXPERIENCED PAIN, AND RESTRICTED RANGE OF MOTION (ROM) DUE TO FAILURE OF FIXATION WITH RECURRENT VARUS DEFORMITY AND SLIPPING OUT OF THE PROXIMAL INTERLOCKING SCREW. THE REPORT STATES, ¿IN THIS CASE, WE USED A BENT NAIL UNLIKE THE OTHER THREE CASES IN WHICH STRAIGHT NAILS WERE USED. WE CONSIDER THIS DIFFERENCE CAN BE A CAUSE OF THIS COMPLICATION. THIS PATIENT ALSO EXPERIENCED F

  Patient problems: Deformity/ Disfigurement; Implant Pain; Loss of Range of Motion

  MAUDE report 14610228 ↗
• InjurySep 15, 2021Fracture; Fracture

  IT WAS REPORTED A REVISION OF THE SURGERY PERFORMED ABOUT A YEAR AGO WAS SCHEDULED DUE TO CONFIRMED POSTOPERATIVE SCREW FRACTURE. HOWEVER, BEFORE THE REVISION, A MISTAKE IN ORDERING THE INSTRUMENTS WAS DISCOVERED AND THE SURGERY WAS POSTPONED. THE PATIENT WAS UNDER GENERAL ANESTHESIA. REVISION SURGERY WAS RESCHEDULED FOR (B)(6) 2021. THIS RECORD CAPTURES THE POSTOPERATIVE SCREW FRACTURE.

  Patient problems: Failure of Implant

  MAUDE report 12478320 ↗