MAUDE Adverse Event Report: K2M, INC., MESA SPINAL SYSTEM; PEDICAL SCREW SPINAL SYSTEM

Catalog Number 801-06540

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/31/2017

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The patient reported hearing a clicking sound and the surgeon determined that the patient had not fused and one pedicle screw had broken and another screw had potentially loosened.There was no reported harm to the patient however the patient was revised on (b)(6) 2017.X-rays were requested for review however not available.The implants that were removed during the revision surgery were retained as medical waste by the hospital and were not returned for examination.Since the removed implants were not available for examination it is not possible to determine the cause of the reported incident conclusively.The surgeon did however determine that the patient had not fused after 12+ months.K2m spinal implants are intended to provide temporary stabilization and should be used as an adjunct to fusion.Spinal implants can be subjected to excessive loading that goes beyond intended design considerations in the case of pseudarthrosis resulting in construct failure.A general manufacturing and inspection records review provided no additional information.

Event Description

On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a post-operative screw back-out.The patient was revised ((b)(6) 2017).(related to 3004774118-2017-00109).

• Brand Name: MESA SPINAL SYSTEM
• Type of Device: PEDICAL 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: 6828200
• MDR Text Key: 83910771
• Report Number: 3004774118-2017-00123
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/31/2017

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: 801-06540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/29/2017
• 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: 801-06550
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR