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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 Problems Break (1069); Activation Failure (3270)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 09/30/2019
Event Type  malfunction  
Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.Additional information: 1 device was labeled for single-use.1 device was not reprocessed or reused.
 
Event Description
This report summarizes 1 malfunction event in which the device broke during deployment inside the patient.The device was left in place, with no adverse consequence to the patient.
 
Event Description
This report summarizes 1 malfunction event in which the device reportedly would not expand or deploy.1 event had no known impact or consequences to the patient.
 
Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h10 1 previously reported event is included in this follow-up record.Product return status 1 device was not available for evaluation.H3 other text : device not returned.
 
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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 Key9245090
MDR Text Key174155816
Report Number0001811755-2019-03420
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number0909000050
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/30/2019
Initial Date FDA Received10/28/2019
Supplement Dates Manufacturer Received09/30/2019
Supplement Dates FDA Received07/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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