MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 11G/15MM IVAS SYSTEM KIT; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)

Catalog Number	0705315000
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during vertebral augmentation the access canula broke while pulling out of the vertebral body.An additional procedure was needed to remove the device material left behind.No further adverse consequences were reported.
Additional Manufacturer Narrative
Corrected data: d10, h6 h3 other text : device not received.
Event or Problem Description
It was reported that during vertebral augmentation the access canula broke while pulling out of the vertebral body.An additional procedure was needed to remove the device material left behind.No further adverse consequences were reported.

• Brand Name: 11G/15MM IVAS SYSTEM KIT
• Common Device Name: INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8915455
• Report Number: 0001811755-2019-02766
• Device Sequence Number: 13910619
• Product Code: OAR
• UDI-Device Identifier: 37613252505960
• UDI-Public: 37613252505960
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0705315000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1