Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M. INC YUKON SPINAL SYSTEM; SPINAL FIXATION SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

K2M. INC YUKON SPINAL SYSTEM; SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 7601-10001
Device Problems Insufficient Information (3190); Migration (4003)
Patient Problem No Information (3190)
Event Date 08/12/2018
Event Type  Injury  
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)(4) 2018 it was reported to k2m, inc.That set screws backed-out approximately 1 month post-operatively.The surgery took place on (b)(6) 2018.Patient was revised on (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 could not be completed as the lot number has not been identified/confirmed in this case.Since the set screw was disposed, 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 a set screw losened approximately 1 month post-operatively.Patient was revised on (b)(6) 2018 (related to 3004774118-00138 and 3004774118-2018-00139).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
YUKON SPINAL SYSTEM
Type of Device
SPINAL FIXATION SYSTEM
Manufacturer (Section D)
K2M. INC
600 hope parkway se
leesburg, va 20175
MDR Report Key7878574
MDR Text Key120333770
Report Number3004774118-2018-00140
Device Sequence Number1
Product Code NKG
Combination Product (y/n)N
PMA/PMN Number
K17144
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7601-10001
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received08/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
1101-90116 LOT FEYY; 1101-90116 LOT UNKNOWN; 7601-10001 UNKNOWN; 7601-90103 LOT GBAF; 7601-9013 LOT UNKNOWN; 1101-90116 LOT UNKNOWN; 7601-10001 UNKNOWN; 7601-9013 LOT UNKNOWN
Patient Outcome(s) Required Intervention;
-
-