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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SPINEJACK EXPANSION KIT 5.0MM; CEMENT, BONE, VERTEBROPLASTY
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STRYKER INSTRUMENTS-KALAMAZOO SPINEJACK EXPANSION KIT 5.0MM; CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number KE001
Device Problems Break (1069); Fracture (1260)
Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Event Date 04/17/2019
Event Type  malfunction  
Event Description
It was reported that the spinejack implant disconnected from the cannula and that one small part of the spinejack implant broke and was cemented into the patient.The procedure was successfully completed and there were no adverse consequences to the patient.
 
Manufacturer Narrative
Additional information added for d10, h3 device evaluation: follow-up report submitted to document the device was not returned, no evaluation is possible.H3 other text : product not returned.
 
Event Description
It was reported that the spinejack implant disconnected from the cannula and that one small part of the spinejack implant broke and was cemented into the patient.The procedure was successfully completed and there were no adverse consequences to the patient.
 
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Brand Name
SPINEJACK EXPANSION KIT 5.0MM
Type of Device
CEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8627722
MDR Text Key145637054
Report Number0001811755-2019-01759
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
PMA/PMN Number
K181262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 08/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberKE001
Was Device Available for Evaluation? No
Date Manufacturer Received08/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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