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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC., EVEREST SPINAL SYSTEM; PEDICAL SCREW SPINAL SYSTEM

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K2M, INC., EVEREST SPINAL SYSTEM; PEDICAL SCREW SPINAL SYSTEM Back to Search Results
Catalog Number E5112-06550
Device Problem Break (1069)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)
Event Date 08/03/2017
Event Type  malfunction  
Manufacturer Narrative
The subject product has not been returned for evaluation.Investigation still in progress.When investigation is complete, k2m, inc.Will file a supplemental report indicating the findings.
 
Event Description
On (b)(6) 2017 it was reported to k2m, inc.That during surgery the polyaxial screw broke.The fractured component was removed and surgery completed.
 
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 fractured components were not returned, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.Over torque, impact or force could contribute to premature tab breakage.No single cause could be determined for this event.
 
Event Description
On (b)(6) 2017 it was reported to k2m, inc.That during surgery the screws extended tab broke prematurely resulting in significant delay of surgery.The fractured component was removed and surgery completed.
 
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Brand Name
EVEREST SPINAL SYSTEM
Type of Device
PEDICAL 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 Key6844839
MDR Text Key85918513
Report Number3004774118-2017-00116
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151727
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue NumberE5112-06550
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/07/2017
Initial Date FDA Received09/06/2017
Supplement Dates Manufacturer Received08/07/2017
Supplement Dates FDA Received10/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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