Direct Inject 79-45903Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327123371), received between Feb 27, 2020 and Nov 5, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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

• InjuryNov 5, 2020Material Erosion; Material Erosion

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR CRANIAL CRANIOTOMY DURING ACOUSTIC SCHWANNOMA REMOVAL SURGERY. A COUPLE WEEKS LATER, LUMBAR SPINE DRAINAGE WAS PERFORMED BECAUSE CEREBROSPINAL FLUID LEAKAGE WAS CONFIRMED FROM THE POSTOPERATIVE WOUND. THE LUMBAR DRAINAGE ELIMINATED THE CSF LEAKAGE, BUT THE BONE CEMENT HAD SOLIDIFIED INSIDE THE SCALP WOUND, HINDERING SPONTANEOUS HEALING. AS A RESULT, A FOLLOW UP SURGERY WAS PERFORMED TO REMOVE THE SUBCUTANEOUS CEMENT AND TREAT WOUNDS.

  Patient problems: Impaired Healing; Inadequate Osseointegration

  MAUDE report 10793120 ↗
• MalfunctionFeb 27, 2020Fracture; Fracture

  IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT DURING THE SURGERY IT WAS NOTICED THE SYRINGE WAS BROKEN.

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

  MAUDE report 9764755 ↗

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