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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 11G/15MM IVAS SYSTEM KIT; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
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STRYKER INSTRUMENTS-KALAMAZOO 11G/15MM IVAS SYSTEM KIT; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT) Back to Search Results
Catalog Number 0705315000
Device Problems Break (1069); Fracture (1260)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 07/24/2019
Event Type  Injury  
Event 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.
 
Manufacturer Narrative
Corrected data: d10, h6 h3 other text : device not received.
 
Event 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.
 
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Brand Name
11G/15MM IVAS SYSTEM KIT
Type of Device
INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8915455
MDR Text Key155041760
Report Number0001811755-2019-02766
Device Sequence Number1
Product Code OAR
UDI-Device Identifier37613252505960
UDI-Public37613252505960
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 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
Device Operator Health Professional
Device Catalogue Number0705315000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/24/2019
Initial Date FDA Received08/21/2019
Supplement Dates Manufacturer Received07/24/2019
Supplement Dates FDA Received07/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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