MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA VOYAGER SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 54750016545

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Spinal Cord Injury (2432)

Event Date 05/06/2021

Event Type  Injury  

Manufacturer Narrative

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 ovf late collapse, undergoing a spinal therapy.It was reported that it was originally fixed at l1-s1, and this time in the additional surgery, it was extended to t10-t12 due to pjk.There was health damage on the patient.The patient experienced lower extremity pain.Initial reporter information and patient information cannot be provided due to the restriction by the privacy regulation.L1 fractured after the operation of l1 / s1 fixation.The existing implants were continued to be left as they were, and fixation was extended with mrc.There was no malfunction with implants.This was a revision surgery.The reported screw was used in initial surgery.Lot unknown.This screw was not explanted.It is implan ted/under continuous use.Reported "extraction" and "disposal" are incorrect.It is unknown if it caused/contributed to the patient's pain.The screw had no malfunction.Initial surgery date: 2020/6/11 initial surgery therapy: l1-s1 fusion: surgical procedure unknown medtronic products used in the initial surgery: sv47 it was unknown what caused the patient injury or if medtronic products caused/contributed to the injury.The sales rep thinks it wasn't due to patient's underlying symptoms.The patient condition has improved.

• Brand Name: CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11911711
• MDR Text Key: 258710637
• Report Number: 1030489-2021-00720
• 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: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 54750016545
• Device Catalogue Number: 54750016545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2021
• 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