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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SPINEJACK CASE KIT 5.0MM; CEMENT, BONE, VERTEBROPLASTY
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STRYKER INSTRUMENTS-KALAMAZOO SPINEJACK CASE KIT 5.0MM; CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number 0909000050
Device Problem Migration (4003)
Patient Problem Pain (1994)
Event Date 12/11/2018
Event Type  Injury  
Manufacturer Narrative
Device implanted and not available for return.
 
Event Description
It was reported that roughly one month after a successfully completed spinejack procedure, that the patient returned with reported pain and radiculopathy.After imaging was performed, the physician observed that one of the implants had gone through the endplate of the vertebral body and that some of the bone had been pushed backwards.Two epidural steroid injections have been administered to the patient since the pain was reported.It was determined that no further surgery or medical intervention was necessary per a surgeon that the patient consulted with.It was further reported by the rep that per the physician commented that he wished he would have used more cement at the time of the initial spinejack procedure and that the patient is osteoporotic.No further adverse consequences have been reported.
 
Manufacturer Narrative
Correction: b2.This correction is being filed to update outcomes attributed to the adverse event.
 
Event Description
It was reported that roughly one month after a successfully completed spinejack procedure, that the patient returned with reported pain and radiculopathy.After imaging was performed, the physician observed that one of the implants had gone through the endplate of the vertebral body and that some of the bone had been pushed backwards.Two epidural steroid injections have been administered to the patient since the pain was reported.It was determined that no further surgery or medical intervention was necessary per a surgeon that the patient consulted with.It was further reported by the rep that per the physician commented that he wished he would have used more cement at the time of the initial spinejack procedure and that the patient is osteoporotic.No further adverse consequences have been reported.
 
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Brand Name
SPINEJACK CASE KIT 5.0MM
Type of Device
CEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8741250
MDR Text Key149413661
Report Number0001811755-2019-02145
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 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 Health Professional
Device Catalogue Number0909000050
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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