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

Catalog Number 2901-10001

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Patient Problem/Medical Problem (2688); No Information (3190)

Event Date 07/17/2017

Event Type  Injury  

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 is complete, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On 7.13.2017 it was reported to k2m, inc.That a patient presented with a possible set screw back-out approximately 4 months post-op.Patient was revised (b)(6) 2017.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.K2m engineering made an in-person visit to the surgeon to discuss the event and final tighten driver options related to his technique.Final tightening technique or other trauma could have contributed to the event but a single cause could not be determined.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.

Event Description

On (b)(6) 2017, it was reported to k2m, inc.That a patient presented with a possible set screw back-out approximately 4 months post-op.Patient was revised (b)(6) 2017.

• 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 ; 5719195195
• MDR Report Key: 6789695
• MDR Text Key: 82563945
• Report Number: 3004774118-2017-00100
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133944
• 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: 07/13/2017

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: 2901-10001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 08/11/2017
• Supplement Dates Manufacturer Received: 07/13/2017
• Supplement Dates FDA Received: 09/15/2017
• 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
• Patient Outcome(s): Required Intervention