MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS AUTOPLEX; BONE CEMENT

Model Number 0607-687-000

Device Problem Use of Device Problem (1670)

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

Event Date 09/13/2019

Event Type  malfunction  

Event Description

The autoplex system without needles was used with the vertaplex hv bone cement during spine procedure.The glue mixed but did not flow through into the syringe properly in order to be used.A second kit was used and a similar thing happened.Only a small amount was available to use in the syringe.

• Brand Name: AUTOPLEX
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9259956
• MDR Text Key: 164456022
• Report Number: 9259956
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0607-687-000
• Device Lot Number: 19149022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Weight: 76