MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO VMXXLCT-AVAMAX¿PLUS ADD TRAY; VERTEBROPLASTY BONE CEMENT

Catalog Number 1040300500

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 02/09/2018

Event Type  malfunction  

Event Description

It was reported that the device packaging was already opened when the customer opened the box.There was no patient involvement as the event occurred prior to the procedure.

Event Description

It was reported that the device packaging was already opened when the customer opened the box.There was no patient involvement as the event occurred prior to the procedure.

Manufacturer Narrative

The device was not returned for evaluation; therefore, a root cause could not be determined for the event.Not received.

• Brand Name: VMXXLCT-AVAMAX¿PLUS ADD TRAY
• Type of Device: VERTEBROPLASTY BONE CEMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7327704
• MDR Text Key: 102079805
• Report Number: 0001811755-2018-00493
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1040300500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1