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

Model Number 55711015525

Device Problems Malposition of Device (2616); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

This part is not approved for use in the united states; device catalog # 55811015525, 510k #k122433 and udi # (b)(4) was cleared 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.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care professional via manufacturer representative regarding screws used in posterior fusion.Levels implanted: t1-11.Pre-operative diagnosis for this procedure ais type2.It was reported that navigation was used from caudal side, the screw was inserted, screws were inserted from the caudal side alternately left and right.It was felt to be deviated a little, so it was checked with ct when coming to th7.It was noted that the screws of the 7th, 8th, and 9th thoracic vertebrae on the left side had deviated.The screw was inserted with navi, but it did not pass through the pedicle and was stuck in the spinal canal.After that, the screw was inserted without using navi with no problem.However, the number of nerve monitoring dropped significantly.After the operation leg moved, but it is unknown at this time whether there were sequelae.The screws were inserted again, and the operation was proceeded and completed.Implant products are being implanted.There was no patient health damage problem.There was a delay of less than 60 min in overall procedure time.

• 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11061838
• MDR Text Key: 226597927
• Report Number: 1030489-2020-01841
• Device Sequence Number: 1
• Product Code: NKB
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2023
• Device Model Number: 55711015525
• Device Catalogue Number: 55711015525
• Device Lot Number: CA15D018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2020
• 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: 12 YR