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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 Use of Device Problem (1670)
Patient Problem Extravasation (1842)
Event Date 12/20/2018
Event Type  Injury  
Manufacturer Narrative
Discarded.
 
Event Description
It was reported that the physicians access cannula placement was too lateral and breached the canal causing cement to leak after the spinejack device was successfully implanted.The leaked cement hardened and an additional procedure was necessary to remove the leaked cement which was completed successfully.
 
Event Description
It was reported that the physicians access cannula placement was too lateral and breached the canal causing cement to leak after the spinejack device was successfully implanted.The leaked cement hardened and an additional procedure was necessary to remove the leaked cement which was completed successfully.
 
Manufacturer Narrative
Correction: b2.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 Key8261211
MDR Text Key133540568
Report Number0001811755-2019-00159
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 Received01/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number0306330000
Was Device Available for Evaluation? No
Date Manufacturer Received11/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SPINEJACK (B)(4); SPINEJACK (B)(4)
Patient Outcome(s) Required Intervention;
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