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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPINEJACK EXPANSION KIT 5.8MM; CEMENT, BONE, VERTEBROPLASTY
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPINEJACK EXPANSION KIT 5.8MM; CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Model Number KE058
Device Problem Activation Failure (3270)
Patient Problem Failure of Implant (1924)
Event Date 04/15/2021
Event Type  Injury  
Manufacturer Narrative
Device implanted.
 
Event Description
It was reported that a spinejack procedure was not completed successfully and unspecified medical intervention was required due to the implant reportedly not expanding and no cement being injected.
 
Manufacturer Narrative
Correction: d9/h3; g3, awareness date.Additional information: b5 executive summary; section e facility information.
 
Event Description
It was reported that an l3 spinejack procedure on an osteoporotic patient who had posterior fixation was not completed successfully due to the implant reportedly not expanding.When attempting to release the implant the release pin broke.Normal instrumentation was used to facilitate removal of the expansion system.No cement was able to be injected.No other adverse consequences or medical intervention was reported.
 
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Brand Name
SPINEJACK EXPANSION KIT 5.8MM
Type of Device
CEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key11815761
MDR Text Key250450971
Report Number3015967359-2021-00853
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 health professional
Type of Report Initial,Followup
Report Date 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberKE058
Device Catalogue NumberKE058
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2021
Date Manufacturer Received06/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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