MAUDE Adverse Event Report: SEASPINE, INC INTERBODY SYSTEM; VERTERBRAL BODY P:ROSTHESIS PRODUCT

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 12/23/2016

Event Type  Injury  

Manufacturer Narrative

No revision surgery is planned.Surgeon has elected to monitor patient at this time.There is no evidence that the device malfunctioned.It is unknown what caused the dysesthesia in the legs.It is unknown if the patient followed post-operative instructions.Patient should be cautioned against early weight bearing and premature ambulation that could lead to loosening and/or failure of the fixators or loss of reduction.It is unknown which concomitant device (if any) or part of the interbody fusion surgical procedure (if any) has caused or contributed to this event, and no conclusion can be drawn.Labeling, warning and precautions: procedures involving bone grafting can produce highly variable results.Significant vascular or neurological impairment proximal to the graft site.Severe vascular or neurological disease.Metabolic or systemic bone disorders that affect bone or wound healing.Severe degenerative bone disease.Uncooperative patients who will not or cannot follow postoperative instructions, including individuals who abuse drugs and/or alcohol.It is not intended to replace or change standard procedures for treatment of bone defects involving bone grafting and fixation.Does not possess sufficient mechanical strength to support the reduction of a graft site prior to tissue in-growth.Therefore anatomical reduction and rigid fixation in all planes should be obtained independently.Device remains in patient.

Event Description

On (b)(6) 2016 (b)(6) female underwent a two level transforaminal lumbar interbody fusion at l4-s1 involving cascadia interbody (k2m inc.), posterior fixation, autograft and bone void grafting biologic devices.Seven to ten days post-operatively the patient reported dysesthesia in their leg.Surgeon reported there was no pedicle screw breach, no nerve root swelling, and no emg changes.At their six week follow up visit patient was doing better but was still in pain.Surgeon has elected to monitor the patient.No medical intervention /revision surgery is planned at this time.

• Brand Name: INTERBODY SYSTEM
• Type of Device: VERTERBRAL BODY P:ROSTHESIS PRODUCT
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: deborah silva ; 5770 armada drive; carlsbad, CA 92008 ; 7602165633
• MDR Report Key: 6337992
• MDR Text Key: 67652654
• Report Number: 2090010-2017-00001
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: No
• 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: CASCADIA INTERBODY, K2MINC; EVO3 PUTTY 10CC; TRINITY ELITE MEDIUM
• Patient Age: 31 YR