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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M. INC YUKON OCT SPINAL SYSTEM; SPINAL FIXATION SYSTEM
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K2M. INC YUKON OCT SPINAL SYSTEM; SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 7601-04526
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 08/14/2018
Event Type  malfunction  
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been returned for evaluation yet.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.
 
Event Description
On (b)(6) 2018 it was reported to k2m, inc that during implantation, a screw broke intra-operatively.Surgery took place (b)(6) 2018.
 
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned to manufacturer for evaluation, and a thorough investigation was completed as the lot number has been identified/confirmed in this case.Since the screw was not returned for evaluation, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.
 
Event Description
On (b)(6) 2018 it was reported to k2m, inc that during implantation, a screw broke intra-operatively.Surgery took place (b)(6) 2018.
 
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Brand Name
YUKON OCT SPINAL SYSTEM
Type of Device
SPINAL FIXATION SYSTEM
Manufacturer (Section D)
K2M. INC
600 hope parkway se
leesburg, va 20175
MDR Report Key7905778
MDR Text Key121595105
Report Number3004774118-2018-00147
Device Sequence Number1
Product Code NKG
Combination Product (y/n)N
PMA/PMN Number
K171444
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 08/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7601-04526
Device Lot NumberGGXC
Was Device Available for Evaluation? No
Date Manufacturer Received08/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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