Direct Inject 79-45905Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · DirectInject On-Demand HA Cement · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327123265), received between May 22, 2019 and Oct 17, 2025 — classified as 6 injuries, 1 malfunction.
The most frequently reported specific device problem is “Migration” (2 reports).
1 FDA recall record name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Apr 1, 2021Terminated
Inability for the user to inject the paste from the syringe into the target location.
Z-1436-2021 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Migration2
- Fracture1
- Loss of or Failure to Bond1
Patient problems
- Unspecified Infection2
- Cerebrospinal Fluid Leakage1
- Inadequate Osseointegration1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration
IT WAS REPORTED THAT DUE TO A TRAUMA, FRAGMENTS OF THE IMPLANT (WHICH WAS INSERTED IN A PRIOR SURGERY) MIGRATED WITHIN THE PATIENT'S BODY.
Patient problems: Pain
MAUDE report 20529738 ↗InjuryJul 14, 2023Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT POST OPERATIVELY, THERE WAS NOTICEABLE SINKING FROM THE SKULL. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 17325421 ↗InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IT WAS NOTICED POST-OP THAT THERE WAS A CEREBROSPINAL FLUID LEAK AT THE SURGICAL SITE. DURING THE REVISION SURGERY, IT APPEARED THAT THE FRAGMENTS OF THE DIRECT INJECT SEEMED TO HAVE MADE A HOLE IN THE MIDDLE OF THE DURAGEN (USED TO CLOSE THE MATER). NO OTHER INFORMATION IS KNOWN AT THIS TIME.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 11732449 ↗InjuryMar 3, 2021Migration; Migration
IT WAS REPORTED THAT THE DIRECTINJECT WAS INJECTED INTO THE SURGICAL SIGHT AND IT WAS NOTICED DURING A POST-OP SCAN, THAT A WHITE FOREIGN SUBSTANCE FLOWED INTO THE DURA. THERE IS NO FURTHER INFORMATION KNOWN AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 11405049 ↗MalfunctionNov 26, 2019Fracture; Fracture
IT WAS REPORTED THAT DURING A RE OPERATIVE PROCEDURE FOR A CSF LEAKAGE, THAT THE 3CM DIAMETER SIZE PASTE INJECTED WITH DIRECTINJECT WAS BROKEN A PART.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9375468 ↗InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH A COMPANY REPRESENTATIVE THAT AN INFECTION OCCURRED WITH A PATIENT AFTER A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY. THERE ARE NO ADDITIONAL DETAILS AVAILABLE AT THIS TIME, AND DEVICE "RELATIVITY"/INVOLVEMENT IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 8632041 ↗
Other METHYL METHACRYLATE FOR CRANIOPLASTY devices
- CRANIOS Reinforced 615.05.01SSynthes GmbH · METHYL METHACRYLATE FOR CRANIOPLASTY17 reports
- CRANIOS Reinforced 615.10.01SSynthes GmbH · METHYL METHACRYLATE FOR CRANIOPLASTY11 reports
- Direct Inject 79-45910Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY7 reports
- CRANIOS Reinforced 615.03.01SSynthes GmbH · METHYL METHACRYLATE FOR CRANIOPLASTY4 reports
- HYDROSET 79-43910Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY4 reports
- StaGraft DBM Putty 92-2004Biomet Orthopedics, LLC · Methyl Methacrylate For Cranioplasty3 reports
- HYDROSET 79-43905Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY2 reports
- Direct Inject 79-45903Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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