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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 11G IVAS ACCESS CANNULA; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
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STRYKER INSTRUMENTS-KALAMAZOO 11G IVAS ACCESS CANNULA; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT) Back to Search Results
Catalog Number 0306330000
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/30/2019
Event Type  Injury  
Manufacturer Narrative
Device not available for return.
 
Event Description
It was reported that the access needle broke in half while in the patient.An additional procedure was performed to remove the device material left behind.No further adverse consequences were reported.
 
Event Description
It was reported that the access needle broke in half while in the patient.An additional procedure was performed to remove the device material left behind.No further adverse consequences were reported.
 
Manufacturer Narrative
This correction is being filed to update outcomes attributed to the adverse event.
 
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Brand Name
11G IVAS ACCESS CANNULA
Type of Device
INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8741573
MDR Text Key149421232
Report Number0001811755-2019-02153
Device Sequence Number1
Product Code OAR
UDI-Device Identifier37613252505991
UDI-Public37613252505991
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number0306330000
Device Lot Number18351012
Was Device Available for Evaluation? No
Date Manufacturer Received11/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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