Direct Inject 79-45910Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327123272), received between Oct 19, 2018 and Jul 31, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K143661); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2024Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO STRYKER THAT THE PATIENT BEGAN EXPERIENCING DISCOMFORT FOUR YEARS AFTER THE MATERIAL WAS INSERTED. IT WAS REPORTED THERE WAS INFLAMMATORY REACTIONS AND SWELLING. A POST OPERATIVE SCAN WAS PERFORMED AND SHOWED THAT THE SWELLING WAS DUE TO THE IMPLANT INSERTED AND A REVISION SURGERY WAS PERFORMED TO REMOVE THE IMPLANT.

  Patient problems: Failure of Implant; Inflammation; Pain; Swelling/ Edema

  MAUDE report 19876295 ↗
• InjuryNov 24, 2021Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS CLEAR FLUID ACCUMULATION AFTER USE OF DIRECTINJECT BONE CEMENT. A REVISION SURGERY WAS CONDUCTED. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: Swelling/ Edema

  MAUDE report 12867775 ↗
• InjuryNov 23, 2021Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS CLEAR FLUID ACCUMULATION AFTER USE OF DIRECTINJECT BONE CEMENT. A REVISION SURGERY WAS CONDUCTED. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: Inflammation

  MAUDE report 12865611 ↗
• MalfunctionMay 18, 2020Migration; Migration

  IT WAS REPORTED TO US THAT THE PRODUCT WAS USED AT THE TIME OF CLOSING THE BURR HOLE AND THE ARTIFICIAL BONE HAD FALLEN INTO THE DURA POST OPERATIVELY. IT WAS REPORTED THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10065093 ↗
• MalfunctionJan 8, 2020Fracture; Fracture

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT WHILE THE SURGEON WAS SQUEEZING OUT DIRECT INJECT, THE TIP OF THE APPLICATOR BROKE, CAUSING THE CONTENTS TO SPILL OUT. BACK UP DIRECT INJECT WAS AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9565123 ↗
• InjuryJun 10, 2019Adverse Event Without Identified Device or Use Problem

  CUSTOMER HAD A CRANIOTOMY AND HAD TO GET A REVISION SURGERY DUE TO A CSF LEAK. CUSTOMER SAID THERE IS NOT A DIRECT PRODUCT COMPLAINT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 8684748 ↗
• InjuryOct 19, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY IN (B)(6) 2017 - DIRECT INJECT WAS USED. NOW, THE PATIENT HAS PRESENTED WITH A REACTION.

  Patient problems: Reaction

  MAUDE report 7985840 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143661. One submission often covers many models, so check the product and lot details in each record.

• Z-1436-2021 · Apr 1, 2021 · Terminated
  DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldabl