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 6550017

Device Problem Device Reprocessing Problem (1091)

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

Event Date 04/27/2021

Event Type  Injury  

Manufacturer Narrative

Delay in procedure of over 60 minutes.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 healthcare professional via a field contact regarding a patient with a pre-operative diagnosis of l4/5 discitis, undergoing a percutaneous spinal fusion and sacrum pelvis fusion therapy.It was reported that the sv56 tab extender and tab were sterilized as they were without disassembling from the previous operation.It was discovered at the time of the second screw placement.It was judged that sterilization was not ensured, the implants that were placed and opened were discarded and all hospital instruments, voyager, solera, etc.Were collected and re-sterilized.The re-sterilization time was 3 hours, and the instruments that were safe until the sterilization was completed, the navigation instruments of the hospital, and the loaned instruments were collected and screw placement was performed to the sacrum and pelvis.There was a delay of over 60 minutes.There were no further patient symptoms/complications.Initial reporter information and patient information cannot be provided due to the restriction by the privacy regulation.It was reported that there was no other malfunction other than being unsterilized.This can be considered a user error.The device is still in use.Extenders were mixed when products were re-sterilized, so the lot number of the reported product could not be confirmed.

• 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: 11839699
• MDR Text Key: 252238426
• Report Number: 1030489-2021-00634
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170679
• 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: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6550017
• Device Catalogue Number: 6550017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other