MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CAPSTONE SPINAL SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 2990001

Device Problem Break (1069)

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

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

Device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the re ported event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent lumbar interbody fusion at l3/4/5 due to degenerative scoliosis.Intra-op, the cage was inserted from the left of l4/5, while being hammered, physician confirmed from the perspective image that the marker looked different from usual.When the physician attempted to adjust the marker to be reflected on the true sagittal, cage broke along with a snap sound.A new cage of one size smaller was opened to deal with issue.No fragment remains in the patient.No patient symptoms or complication were reported as result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent lumbar interbody fusion at l3/4/5 due to degenerative scoliosis.Intra-op, the cage was inserted from the left of l4/5, while being hammered, physician confirmed from the perspective image that the marker looked different from usual.When the physician attempted to adjust the marker to be reflected on the true sagittal, the inserter broke along with a snap sound.No fragment remains in the patient.No patient symptoms or complication were reported as result of this event.

Manufacturer Narrative

Product analysis result: visual and optical inspection of the threaded inserter confirmed the bottom tab of the tip is broken; the broken tab is missing and not returned for analysis.The fracture initiation appears to be located at the base of the tab.Microscopic examination of the fracture surface reveals a relatively quasi-brittle fracture, with no indication of fatigue.This type of damage is consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSTONE SPINAL 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: 8105002
• MDR Text Key: 128387901
• Report Number: 1030489-2018-01559
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00613994803061
• UDI-Public: 00613994803061
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103731
• 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,Followup
• Report Date: 04/04/2019

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: 2990001
• Device Lot Number: NM16D012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/27/2018
• Supplement Dates Manufacturer Received: 10/29/2018; 03/12/2019
• Supplement Dates FDA Received: 11/27/2018; 04/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2016
• 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: 71 YR