MAUDE Adverse Event Report: Stryker Orthopaedics-Limerick HYDROSET/10CC INJECTBLE CEMENT; Bone matrix implant, synthetic, non-antimicrobial

Catalog Number	79-43910
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: HYDROSET/10CC INJECTBLE CEMENT
• Common Device Name: Bone matrix implant, synthetic, non-antimicrobial
• Manufacturer (Section D): Stryker Orthopaedics-Limerick; raheen business park; limerick NA ; EI NA
• Manufacturer (Section G): Stryker Orthopaedics-Limerick; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: tanja büchel ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; +49()7614888208
• MDR Report Key: 50911811
• Report Number: 0008010177-2026-00182
• Device Sequence Number: 5330311
• Product Code: GXP
• UDI-Device Identifier: 07613154275014
• UDI-Public: 07613154275014
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 79-43910
• Device Lot Number: 5B5S9IC04034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown