MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC TRANSLACE SPINAL TETHERING SYSTEM

Catalog Number 8205300

Device Problem Mechanical Problem (1384)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Product code: owi: bone fixation cerclage, sublaminar.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

It was reported that the patient underwent posterior lumbar fusion and fixation at t6-l3 due to kyphosis.After approximately one week post-op, patient had fever.When evaluation was performed, infection was found.Hence, a revision surgery was performed for the removal of all implants on (b)(6) 2019.During the revision surgery, it was found that the connectors were very tight and it was difficult to remove the connectors.The removal was carried out by grasping the rod with a rod gripper.No tensioner was used.The severity of the infection was determined to be not serious.Allegedly, the patient has still not recovered.The relatedness of the infection with the implants or surgical procedure could not be determined.

• Brand Name: TRANSLACE SPINAL TETHERING SYSTEM
• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8531075
• MDR Text Key: 142470755
• Report Number: 1030489-2019-00442
• Device Sequence Number: 1
• Product Code: OWI
• UDI-Device Identifier: 00763000108380
• UDI-Public: 00763000108380
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K163181
• 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
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8205300
• Device Lot Number: CT17F019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention