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

Catalog Number	2911-06550
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been returned for evaluation.Investigation is still in process.When investigation of the subject part is complete, k2m inc.Will file a supplemental report indicating the findings.
Event or Problem Description
On 12/27/2016 it was reported to k2m, inc.That a patient presented with a screw head separated from the screw shaft.The patient reportedly had a screw head separated from the screw shaft approximately 5 months post-op.
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.While this incident was most likely caused by excessive bending and anatomical forces, no root causes could be determined based on the information provided.However, this was determined to be an isolated incident, as this is the first time we have received a report for this type of failure since the launch of the system approximately six years ago.While the implant was not returned, a general review of the manufacturing and inspection records revealed no additional information.In situ.
Event or Problem Description
On (b)(6) 2016 it was reported to k2m, inc.That a patient presented with a screw head separated from the screw shaft.The patient reportedly had a screw head separated from the screw shaft approximately 5 months post-op.

• Brand Name: EVEREST SPINAL SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 6277258
• Report Number: 3004774118-2016-00121
• Device Sequence Number: 13653851
• Product Code: NKB
• UDI-Device Identifier: 10888857042353
• UDI-Public: 10888857042353
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K133944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2016

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
• Operator of Device: Physician
• Device Catalogue Number: 2911-06550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2017
• Supplement Report FDA Received Date: 02/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1