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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. DENALI SPINAL SYSTEM; PEDICLE SCREW SPINAL SYSTEM
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K2M, INC. DENALI SPINAL SYSTEM; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 111-B55500-SG
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 12/07/2016
Event Type  Injury  
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product was returned for evaluation but evaluation is still in progress.Upon completion of evaluation of the subject part, k2m inc.Will file a supplemental report indicating the findings.
 
Event Description
On 03.21.2017 it was reported to k2m, inc.That a revision surgery took place in which screws were removed.Revision surgery took place (b)(6) 2016.
 
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product was returned for evaluation but evaluation is still in progress.Upon completion of evaluation of the subject part, k2m inc.Will file a supplemental report indicating the findings.Evaluation in process.
 
Event Description
On 03.21.2017 it was reported to k2m, inc.That a revision surgery took place in which all hardware was removed.Revision surgery took place (b)(6) 2016.
 
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Brand Name
DENALI SPINAL SYSTEM
Type of Device
PEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
Manufacturer (Section G)
K2M, INC.
600 hope parkway se
leesburg VA 20175
Manufacturer Contact
sandra gilbert
600 hope parkway se
leesburg, VA 20175
5719195195
MDR Report Key6506931
MDR Text Key73227016
Report Number3004774118-2017-00034
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue Number111-B55500-SG
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received03/21/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
THE 101-10001 LOT JKB; THE 101-73040 LOT PUY; THE 101-80028 LOT BMH; THE 801-36535M LOT JEY; THE 801-36540 LOT LAB; THE 801-36540M LOT RLW; THE 801-36545M LOT RLX
Patient Outcome(s) Required Intervention;
Patient Age24 YR
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