MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CD HORIZON LEGACY SPINAL SYSTEM

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore cause of event cannot be determined.

Event Description

It was reported that on (b)(6) 2008, patient underwent plif at levels l3-l5 due to lumbar canal stenosis.Hook was placed on one side of l3.On an unknown date post-op, rod breakage between l3 hook and l4 was found on the right side.Surgeon commented that the one-side fixation might have negatively contributed to the event.He also commented that the event did not significantly worsen the patient's adl.Revision surgery was done on (b)(6) 2015.The surgeon replaced l4 screw at one side because it was loosened, but he decided to replace all the screws also with s5 screws as the patient was still young.He performed two intervertebral plif at l4-l5-s1.

Manufacturer Narrative

Additional information: x-ray review h6:x-ray review: levels implanted appear to be l3-4 with pedicle screw instrumentation with a unilateral extension to l2 on right.This does not match the event description of l3-5 fusion.There is a fracture of the rod between the l2 laminal back and l3 pedicle screw.This is a post op film, pre-revision.It is difficult to determine if bony fusion is present,but doubtful at this short interval from surgery.No intervertebral graft is present at l2-3.Root cause surgical technique.

• Brand Name: CD HORIZON LEGACY SPINAL SYSTEM
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5133751
• MDR Text Key: 27804797
• Report Number: 1030489-2015-02577
• Device Sequence Number: 0
• Product Code: OSH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2015
• 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
• Patient Age: 00057 YR