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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AFB1115-AVAFLEX BALLOON 11G 15MM; CEMENT, BONE, VERTEBROPLASTY
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STRYKER INSTRUMENTS-KALAMAZOO AFB1115-AVAFLEX BALLOON 11G 15MM; CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Model Number 1031115000
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/17/2020
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility, while the cannula was positioned in the patient, rapid repositioning of the patient was required to address an emergency.Medical personnel applied sideways force while removing the cannula as quickly as possible due to the emergency, breaking the cannula.No patient harm resulted from the broken cannula.
 
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Brand Name
AFB1115-AVAFLEX BALLOON 11G 15MM
Type of Device
CEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key11170382
MDR Text Key226813950
Report Number0001811755-2021-00090
Device Sequence Number1
Product Code NDN
UDI-Device Identifier07613327374605
UDI-Public07613327374605
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162062
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1031115000
Device Catalogue Number1031115000
Device Lot Number6372836
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2020
Date Manufacturer Received12/17/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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