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

Catalog Number	2901-10001
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product will not be returned for evaluation.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.Discarded by user.
Event or Problem Description
On (b)(6) 2017 it was reported to k2m, inc.That a revision surgery took place in which a migrated set screw was removed.The patient reportedly had set screws back-out approximately 4 months post-op.Revision surgery took place (b)(6) 2016.
Additional 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 set screw was discarded, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.It is reported that the surgeon does not use reduction instrumentation, which may have contributed to this incident, as the clamping force on the rod decreases with increased resistance to the set screw due to rod reduction without reduction instrumentation.While none of the implants were returned, a general review of the manufacturing and inspection records revealed no additional information.Discarded by user.
Event or Problem Description
On (b)(6) 2017 it was reported that a revision surgery took place in which a lateral offset connector and set screw were removed.The patient reportedly had a connector set screw back-out approximately 3 months post-op.Revision surgery took place (b)(6) 2016.

• 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: 6399494
• Report Number: 3004774118-2017-00023
• Device Sequence Number: 976002
• Product Code: NKB
• UDI-Device Identifier: 10888857038714
• UDI-Public: 10888857038714
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K143334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Catalogue Number: 2901-10001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2017
• Supplement Report FDA Received Date: 04/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention