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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-LEESBURG ALEUTIAN INTERBODY SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-LEESBURG ALEUTIAN INTERBODY SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 602-90780
Device Problem Break (1069)
Patient Problems No Patient Involvement (2645); No Information (3190)
Event Date 04/02/2019
Event Type  Injury  
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.Upon review of the inner shaft, it was observed that the threaded component at the distal tip had fractured off the instrument.The fracture face exhibited a high-low cross-section, indicating that the failure occurred due to bending overload.Off-axis impaction may have compounded forces at the joint of the threads.
 
Event Description
On 04.02.2019 it was reported to k2m, inc.That a surgery took place in which a inserter inner shaft broke at the tip during insertion.The tip of the broken inserter inner shaft remains in the patient.
 
Manufacturer Narrative
This has been determined to be a duplicate of manufacturer's report number 3004774118-2019-01067.
 
Event Description
This has been determined to be a duplicate of manufacturer's report number 3004774118-2019-01067.
 
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Brand Name
ALEUTIAN INTERBODY SYSTEM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-LEESBURG
600 hope parkway se
leesburg VA 20175
MDR Report Key8755633
MDR Text Key150427164
Report Number3004774118-2019-00067
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K160547
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number602-90780
Device Lot NumberFXMV
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2019
Date Manufacturer Received10/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
6101-90167 LOT FWCJ
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