MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC T2 ALTITUDE EXPANDABLE CORPECTOMY SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 9411200

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

Product was not 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 corpectomy surgery at t6 (right side anterior lateral approach) due to ankylosing spondylitis cord compression.Intra-op, the inserter broke while implanting the cage.The surgeon was concerned about the sterility of the driver, and the inserter was removed in sterile manner and surgical gloves were changed.No parts of the product were left in the patient.No harm was caused to the patient.

Manufacturer Narrative

Product analysis results: visual optical visual and optical examination confirmed the thumb wheel of the inserter has broken off the back side of the shaft at the weld.Optical inspection did not reveal any defects in the weld that could contribute to the weld failing.The breakage of the instrument is consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: T2 ALTITUDE EXPANDABLE CORPECTOMY SYSTEM
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 8559866
• MDR Text Key: 143375056
• Report Number: 1030489-2019-00488
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00613994730275
• UDI-Public: 00613994730275
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100976
• 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,Followup
• Report Date: 07/04/2019

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 Catalogue Number: 9411200
• Device Lot Number: CA10M032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 04/09/2019
• Supplement Dates FDA Received: 07/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2010
• 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 Age: 57 YR
• Patient Weight: 79