MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 8G VERTEPORT CEMENT CANNULA; INJECTOR, VERTEBROPLASTY

Catalog Number 0306310000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Extravasation (1842)

Event Date 09/21/2015

Event Type  malfunction  

Event Description

It was reported that the verteport cannula was longer than the surgeon expected, which resulted in the physician protruding through the anterior wall of the vertebral body which led to the cement being injected outside the vertebral body.There were no other reported adverse consequences, medical intervention or procedural delays.

Manufacturer Narrative

Device not returned.

Event Description

It was reported that the verteport cannula was longer than the surgeon expected, which resulted in the physician protruding through the anterior wall of the vertebral body which led to the cement being injected outside the vertebral body.There were no other reported adverse consequences, medical intervention or procedural delays.

• Brand Name: 8G VERTEPORT CEMENT CANNULA
• Type of Device: INJECTOR, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; highway #3, km 130.2; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5164484
• MDR Text Key: 28801092
• Report Number: 0001811755-2015-03855
• Device Sequence Number: 1
• Product Code: OAR
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0306310000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2015
• 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