HYDROSET 79-43910Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · 10CC HYDROSET INJECTABLE CEMENT · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613154275014), received between Jul 31, 2024 and Sep 28, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Device Dislodged or Dislocated1
- Fracture1
Patient problems
- Convulsion/Seizure2
- Cerebrospinal Fluid Leakage1
- Failure of Implant1
- Inflammation1
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Device Dislodged or Dislocated
It was reported that, a few months after implantation, the HydroSet cranial flap was observed to have shifted from its intended position, due to intracranial fluid pressure. Revision surgery is planned to replace the cranial flap.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 50911811 ↗InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRODUCT WORKED AS INTENDED DURING THE CASE; HOWEVER, THE PATIENT WITH CEMENT IMPLANT EXPERIENCED CONVULSIONS AFTERWARD.
Patient problems: Convulsion/Seizure
MAUDE report 24454835 ↗InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRODUCT WORKED AS INTENDED DURING THE CASE; HOWEVER, THE PATIENT WITH CEMENT IMPLANT EXPERIENCED CONVULSIONS AFTERWARD.
Patient problems: Convulsion/Seizure
MAUDE report 24454833 ↗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 19876280 ↗
Other METHYL METHACRYLATE FOR CRANIOPLASTY devices
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- 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
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.