MAUDE Adverse Event Report: STRYKER CORPORATION AUTOPLEX; BONE CEMENT

Catalog Number 0607687000

Device Problems Leak/Splash (1354); Obstruction of Flow (2423); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/06/2018

Event Type  malfunction  

Event Description

Nurse mixed the cement and doctor started injecting into the patient.He realized that the cement was no longer entering the patient and we realized it was coming out of a different hole and the vertaport seemed to be clogged.The case continued and was completed with no harm to the patient.The injector syringe of bone cement leaked between syringe and attachment.Per site reporter: i spoke to stryker and they are sending me a shipping label.

• Brand Name: AUTOPLEX
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER CORPORATION; 4100 east milham ave.; kalamazoo MI 49001
• MDR Report Key: 7788267
• MDR Text Key: 117292014
• Report Number: 7788267
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0607687000
• Device Lot Number: 18187012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/14/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31025 DA