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

Model Number 6642007

Device Problems Use of Device Problem (1670); Material Deformation (2976)

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

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned device was not completed at the time of this report.A follow up report will be sent when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via field representative regarding a patient who undergone spinal therapy with an indication of lumbar spinal canal stenosis.It was reported that during olif+pps procedure the instrument was shipped from (b)(4) for the operation of (b)(6).The instrument was used for continuous diversion on (b)(6).The sales rep attended the operation remotely on (b)(6) and did not attend the operation on (b)(6).They tried to attach the screw to the tab extender in the operation on (b)(6) but failed.When checked the tab extender, the screw tab for the previous operation was still attached to the tab extender.Since 8units (4 screws) could be used without any problem, operation was completed.The person in charge and the distributer did not notice that the tab remained, so they diverted the product in the operation as it was.The orthopedic nurse leader confirmed with the nurse in charge that the tab had not been removed.There was no delay in overall procedure time.No patient symptoms or complications as a result of this event.Levels implanted l4/5.Product used correctly according to the directions given in the ifu/labeling.There was no device breakage.It was reported that five sv47 tab extenters were returned.Deformation was found at screw tab connection and cap connection faces.Screw tab was not returned.

• Brand Name: CD HORIZON SOLERA VOYAGER 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: 11722510
• MDR Text Key: 251733345
• Report Number: 1030489-2021-00522
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143375
• 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: 04/26/2021

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 Model Number: 6642007
• Device Catalogue Number: 6642007
• Device Lot Number: KH18A103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/03/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1