MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO VMX00CT-AVAMAX PLUS KIT; VERTEBROPLASTY BONE CEMENT

Catalog Number 1040300000

Device Problem Burst Container or Vessel (1074)

Patient Problem Eye Injury (1845)

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

Device discarded.

Event Description

It was reported that while injecting cement the mixer broke and a projectile hit the physician in the eye.There was no patient involvement and the case was completed successfully.It was further reported that the physician was wearing protective eyewear at the time of the event and went to the emergency room to be evaluated but it was not reported whether medical intervention was necessary.

• Brand Name: VMX00CT-AVAMAX PLUS KIT
• Type of Device: VERTEBROPLASTY BONE CEMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7134287
• MDR Text Key: 95512236
• Report Number: 0001811755-2017-02476
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1040300000
• Device Lot Number: 0001083487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1