MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number G75446545

Device Problem Malposition of Device (2616)

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

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog # 75446545, 510k #k042025 was approved for sales in the united states.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

It was reported that the patient underwent posterior lumbar fusion (plf) at l4-5 due to lumbar canal stenosis.During the surgery, one pedicle screw that was inserted in the patient had deviated.This was found after the surgery was complete.The ct/mri indicated that the pedicle screw (ps) had backed out.The back-out was technical error.Hence, a revision surgery was performed on the same day in which it was explanted completely.The surgeon tried to insert the screw with changing angle of the screw, but the head of mas was completely locked and it could not be engaged with a screw driver.The screw was removed and replaced to the new one with changing the direction.There was a delay of less than 60 minutes in the overall procedure time.No patient complications were reported as a result of this.

Manufacturer Narrative

Additional information: product analysis- the screw was returned with the head locked.There are witness marks in the saddle of the screw indicating that the rod and the set screw had been locked into place.The witness marks do not line up with the cut out in the head, indicating the mas was loosened and re-tightened.This does not appear to be a failure of the mas as it appears to have performed to the design intent.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6950750
• MDR Text Key: 89360731
• Report Number: 1030489-2017-02200
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/01/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G75446545
• Device Lot Number: H5313986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 10/16/2017
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2016
• 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