MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 5484801

Device Problem Difficult To Position (1467)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Submitted pictures appear to display a witness mark consistent with significant force.Device evaluation anticipated, but not yet begun.

Event Description

It was reported that a patient underwent me-tlif at l3-5 levels.During surgery, dura injury occurred when the cage was removed with curved adjustor endoscopically.It was rotated during insertion but placed obliquely.The surgeon tried to remove and re-insert but it could not be hooked well and dura injury occurred by momentum of removal.Reduction extender was come off twice during posterior fusion at l3-5 levels.The surgeon inserted the rod via other incision with longitude inserter for l4 reduction because the patient had scoliosis.The rod was pushed down at l3 and l5 extender alternately but it became hard to push around indicating.The surgeon loosed and tried a few times while changing extender angle to screw axis (it was angled unusual position for the reduction because it were interfered each other as a result of that it were bulky and screws were very close) and l3 extender was come off around left on the indicator with sound (it did not look damage).It could not reconnect with rrp due to muscle interferer.The surgeon loosed other extender and tried again but it was failed.The surgeon connected the extender after the screw was removed.L5 extender was also come off and could not reconnect with rrp etc.The surgery was changed to open surgery.The surgical time was extended 31-60 min as a result of the event.The products came in contact with the patient.No patient complications were reported.No medtronic cage and screws were involved to the event.Also no problem were reported to inner sleeve.Milestone peek at l3/4 level was inserted via tubular on the left approach.Dura injury occurred when the cage was removed.The surgeon gave up to remove the cage and used bolheal for the dura damge.The event was occurred during fixation on the right side after l4/5 cage insertion, left fixation and rod placement.After insertion of screws and pre-bend rod with a longitude inserter, a rod was pushed down at l3 and l5 alternately but it was stopped around indicating.The surgeon had tried to adjust but l3 extender was come off around left on the indicator.The sales rep tied to stop the surgeon because a lot of force seemed to be loaded but it was late.It could not reconnected with rrp due to muscle interferer.The surgeon connected the extender after the screw was removed.L5 extender also came off and could not reconnect with rrp and pusher.All extenders and rods were removed, and then the surgery was changed to open surgery.

Manufacturer Narrative

Additional information: product analysis:after visual, optical and functional evaluation, no evidence was found that would suggest a defect in manufacturing or processing of the implant or associated components.The instrument appears to be capable of performing its intended function.

Manufacturer Narrative

Corrected information: if information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• 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: 5133757
• MDR Text Key: 28077281
• Report Number: 1030489-2015-02579
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Followup,Followup
• Report Date: 10/27/2015

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5484801
• Device Lot Number: SV12C055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 00070 YR