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

Catalog Number	M5111-05540
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/07/2016
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.User disposed.
Event or Problem Description
On (b)(6) 2017 it was reported to k2m, inc.That a revision surgery took place in which a loosened pedicle screw was removed.The patient reportedly had a pedicle screw loosen approximately 3 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.Almost three months post-op, the patient was revised due to a grade 1 anterolisthesis at l4-l5.During the revision surgery, the surgeon noticed that the left l4 set screw was loose and the right l4 pedicle screw was displaced laterally through the pedicle.The surgeon believes that the set screw may have been cross-threaded, possibly contributing to it backing out, resulting in the right l4 pedicle screw displacing through the patient's pedicle.The explanted implants were disposed of, and therefore, could not be evaluated.Based on the information provided, no root causes could be determined.While none of the implants were returned, a general review of the manufacturing and inspection records revealed no additional information.User disposed.
Event or Problem Description
On (b)(6) 2017 it was reported to k2m, inc.That a revision surgery took place in which a loosened pedicle screw was removed.The patient reportedly had a pedicle screw loosen 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: 6297025
• Report Number: 3004774118-2017-00002
• Device Sequence Number: 1081102
• Product Code: MNI
• UDI-Device Identifier: 10888857148956
• UDI-Public: 10888857148956
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K132361
• 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): 01/09/2017

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: M5111-05540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 02/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2901-10001 LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 78