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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. NILE ALTERNATIVE FIXATION SPINAL SYSTEM; BONE FIXATION CERCLAGE
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K2M, INC. NILE ALTERNATIVE FIXATION SPINAL SYSTEM; BONE FIXATION CERCLAGE Back to Search Results
Catalog Number 5401-85500
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Bone Fracture(s) (1870)
Event Date 10/11/2016
Event Type  malfunction  
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 10/19/2016 it was reported to k2m, inc.That a surgery took place in which a nile clamp was implanted and explanted multiple times due to motor signal loss.Lamina fracture was noticed at the level of issue.Surgery took place (b)(6) 2016.
 
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, and distribution records according to the description of the product(s) used was conducted.All records revealed that all product(s) lots were manufactured within specifications and distributed in accordance with all operating procedures.The reported difficulty in inserting the set screw was likely caused by the clamp being implanted and explanted multiple times.The fractured lamina of the patient was likely caused by the multiple attempts of tensioning and loosening the clamp on the lamina.Our investigation of the product and review of the manufacturing and inspection records revealed no manufacturing discrepancies or material defects, nor did it reveal any contributing information/trends.
 
Event Description
On 10/19/2016 it was reported to k2m, inc.That a surgery took place in which a nile clamp was implanted and explanted multiple times due to motor signal loss.Lamina fracture was noticed at the level of issue.After repeated removals and replacement there was difficulty inserting one of the set screws.Surgery took place (b)(6) 2016.
 
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Brand Name
NILE ALTERNATIVE FIXATION SPINAL SYSTEM
Type of Device
BONE FIXATION CERCLAGE
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
5719192000
MDR Report Key6113646
MDR Text Key60423828
Report Number3004774118-2016-00094
Device Sequence Number1
Product Code OWI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143350
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 10/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue Number5401-85500
Device Lot NumberEPAH
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received10/19/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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