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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. SET SCREW; POSTERIOR CERVICAL SCREW SYSTEM
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K2M, INC. SET SCREW; POSTERIOR CERVICAL SCREW SYSTEM Back to Search Results
Catalog Number 7601-10001
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 04/01/2019
Event Type  Injury  
Manufacturer Narrative
Return status of the device/devices is currently unknown.
 
Event Description
Five yukon set screws migrated post-operatively.The patient will undergo revision surgery in the future.This record captures the forth of the five screws.
 
Event Description
Five yukon set screws migrated post-operatively.Explant surgery has occurred.This record captures the forth of the five screws.
 
Manufacturer Narrative
Correction to d.3.And g.1.: updated from 'stryker spine- (b)(6)' to 'k2m, inc.' correction to d.4.: updated from unknown to hnph.It was reported that three yukon oct polayxial screws, spanning levels c4-c6, pulled out of the lateral mass approximately six months post-operatively.According to the rep, the set screws were still properly seated within the screws.No issue related to the reported event was found with this product; therefore, it is a concomitant product.
 
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Brand Name
SET SCREW
Type of Device
POSTERIOR CERVICAL SCREW SYSTEM
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key9131322
MDR Text Key165538284
Report Number3004774118-2019-00105
Device Sequence Number1
Product Code NKG
UDI-Device Identifier10888857328310
UDI-Public10888857328310
Combination Product (y/n)N
PMA/PMN Number
K171444
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7601-10001
Device Lot NumberHNPH
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2019
Date Manufacturer Received10/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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