Direct InjectRecalls & reported problems across all models

We found 3 models of Direct Inject by Stryker Leibinger GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 16 adverse event reports in the FDA's MAUDE database, received between Oct 19, 2018 and Oct 17, 2025 — classified as 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Direct Inject recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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 · Recall details · FDA record ↗

Most reported Direct Inject problems

Direct Inject models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Direct Inject 79-45905

  METHYL METHACRYLATE FOR CRANIOPLASTY
  1 recall7 reports
• Direct Inject 79-45910

  METHYL METHACRYLATE FOR CRANIOPLASTY
  7 reports
• Direct Inject 79-45903

  METHYL METHACRYLATE FOR CRANIOPLASTY
  2 reports

Recent Direct Inject adverse event reports

The 15 most recent reports across all models, 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

  NO NEW INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 23322978 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 Stryker Leibinger GmbH & Co. KG products

• SMARTLOCK17 models · 64 reports
• SPINEMAP2 models · 58 reports
• MEDPOR TITAN5 models · 6 reports · 1 recall
• MEDPOR25 models · 49 reports