MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 11G IVAS ACCESS CANNULA; INJECTOR, VERTEBROPLASTY

Catalog Number 0306330000

Device Problem Material Fragmentation (1261)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 06/15/2015

Event Type  malfunction  

Event Description

It was reported that during a vertebroplasty the trocar fractured at the entrance to the pedicel.The surgeon determined it was safe to leave the fragment in place.There was a 57 minute procedural delay to take the patient to radiology for a ct scan which then delayed the arrival to the outpatient area and their release.

Manufacturer Narrative

Device not returned.

Event Description

It was reported that during a vertebroplasty the trocar fractured at the entrance to the pedicel.The surgeon determined it was safe to leave the fragment in place.There was a 57 minute procedural delay to take the patient to radiology for a ct scan which then delayed the arrival to the outpatient area and their release.

Event Description

It was reported that during a vertebroplasty the trocar fractured at the entrance to the pedicel.The surgeon determined it was safe to leave the fragment in place.There was a 57 minute procedural delay to take the patient to radiology for a ct scan which then delayed the arrival to the outpatient area and their release.

• Brand Name: 11G IVAS ACCESS CANNULA
• Type of Device: INJECTOR, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; highway #3, km 130.2; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5063716
• MDR Text Key: 25227265
• Report Number: 0001811755-2015-03276
• 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: Followup,Followup
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0306330000
• Device Lot Number: 15041012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2015
• 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
• Patient Outcome(s): Other