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

Catalog Number 55711015550

Device Problem Malposition of Device (2616)

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

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

This part is not approved for use in the us, however a like device with part# 55811015550, 510k# k122433, and (b)(4) is approved for market in the us.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

Pre-operative diagnosis for this procedure: kyphosis due to compression fracture procedure used: posterior fusion at t11-l2 / kyphosis correction procedure with trauma levels: t11-l2 it was reported that x-rays and cts taken after insertion of the screw during surgery, revealed that the l2 right screw was found to be inserted in the vertebral body not via the pedicle from lateral side.The observation was made after inserting the rod and closing the incision.The screw was reinserted.No patient complications were reported as a result of the event.

Manufacturer Narrative

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): SOFAMOR DANEK; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): SOFAMOR DANEK; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6607345
• MDR Text Key: 76496067
• Report Number: 1030489-2017-01416
• 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: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 55711015550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2017
• Initial Date FDA Received: 06/02/2017
• Supplement Dates Manufacturer Received: 05/10/2017
• Supplement Dates FDA Received: 10/04/2017
• 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