MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC T2 STRATOSPHERE EXPANDABLE CORPECTOMY SYSTEM

Model Number 436113A

Device Problem Mechanics Altered (2984)

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

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: part # 436113a lot # ca18j197 visual inspection of the centerpiece expander did not reveal any damages that would hinder the implant from expanding.Optical inspection revealed one of the gears/teeth has been damaged and deformed.Functional test with a sample 13mm inserter confirmed the centerpiece would not open smoothly and collapse.The issue appears to be where the tip of the expansion shaft contacts the teeth and cage of the centerpiece when the expansion shaft is inserted and turned.Per the print 436120a-e on note 7 rev-c, with the locking set screw backed out, the assembly must be able to smoothly expand and collapse.This issue is being investigated on capa 471462.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via the manufacturer representative of an event occurred during an unknown s pinal procedure for a patient diagnosed with kyphosis of th12.It was also reported that, after performing th12 pvcr, the t3 cage was inserted from the posterior side and was lengthened, but it didn't contract when attempt was made to change its position.Hence, the cage was explanted and was replaced with another one.Overall delay in the procedure was of less than 60 minutes.Product return was requested, and both it was replaced with medtronic product.No injury / complication was reported in the patient.

• Brand Name: T2 STRATOSPHERE EXPANDABLE CORPECTOMY 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: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11257113
• MDR Text Key: 229593552
• Report Number: 1030489-2021-00116
• Device Sequence Number: 1
• Product Code: PLR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2021

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: 436113A
• Device Catalogue Number: 436113A
• Device Lot Number: CA18J197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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: 63 YR