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

Catalog Number M5111-05540

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 12/07/2016

Event Type  Injury  

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 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.

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 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
• Type of Device: PEDICLE 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 ; 5719192000
• MDR Report Key: 6297025
• MDR Text Key: 66433560
• Report Number: 3004774118-2017-00002
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 10888857148956
• UDI-Public: 10888857148956
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Physician
• Device Catalogue Number: M5111-05540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 02/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/28/2017
• 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 Number: 1
• Treatment: 2901-10001 LOT UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 78