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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AUTOPLEX SYSTEM: W/ VERTAPLEX HV; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
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STRYKER INSTRUMENTS-KALAMAZOO AUTOPLEX SYSTEM: W/ VERTAPLEX HV; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT Back to Search Results
Catalog Number 0607687000
Device Problem Insufficient Information (3190)
Patient Problem Extravasation (1842)
Event Date 03/29/2019
Event Type  Injury  
Manufacturer Narrative
Device not available.
 
Event Description
It was reported that a patient who had received a vertebralplasty procedure had returned to the hospital complaining of shortness of breath.After a ct scan was performed, cement was located in the patient's lungs and heart.Attempts are being made to obtain additional information from the user facility.
 
Manufacturer Narrative
This correction is being filed to update outcomes attributed to the adverse event.
 
Event Description
It was reported that a patient who had received a vertebralplasty procedure had returned to the hospital complaining of shortness of breath.After a ct scan was performed, cement was located in the patient's lungs and heart.Attempts are being made to obtain additional information from the user facility.
 
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Brand Name
AUTOPLEX SYSTEM: W/ VERTAPLEX HV
Type of Device
POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8578444
MDR Text Key143999352
Report Number0001811755-2019-01588
Device Sequence Number1
Product Code LOD
UDI-Device Identifier37613252039250
UDI-Public37613252039250
Combination Product (y/n)N
PMA/PMN Number
K032945
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 11/30/2020
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 Number0607687000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/05/2019
Initial Date FDA Received05/03/2019
Supplement Dates Manufacturer Received11/28/2020
Supplement Dates FDA Received11/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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