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

Catalog Number	9411200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 8559866
• Report Number: 1030489-2019-00488
• Device Sequence Number: 19216774
• Product Code: MQP
• UDI-Device Identifier: 00613994730275
• UDI-Public: 00613994730275
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 07/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 79