MAUDE Adverse Event Report: STRYKER CORPORATION IVAS ELITE FRACTURE KIT 11G 15.0 MM; CEMENT, BONE, VERTEBROPLASTY

Model Number 0808-115-800

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2023

Event Type  malfunction  

Event Description

The balloon cannula was leaking and would not inflate.

• Brand Name: IVAS ELITE FRACTURE KIT 11G 15.0 MM
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 18158707
• MDR Text Key: 328383744
• Report Number: 18158707
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0808-115-800
• Device Catalogue Number: 0808-115-800
• Device Lot Number: 23159012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2023
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31025 DA
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Race: White