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 08/10/2018

Event Type  malfunction  

Manufacturer Narrative

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

Pre-operative diagnosis: lumbar spinal canal stenosis procedure: transforaminal lumbar interbody fusion levels: l4-s it was reported that intra-op, the tip the claw part on the one side of the inserter was deformed.It was wobbly and it was broken when it was touched.The product came in contact with the patient.No symptoms or complications were reported.No fragments remain in the patient.

Manufacturer Narrative

Product analysis: visual and optical examination of the returned instrument confirmed one of the tangs at the tip of the inserter has been broken off.The fracture surface is relatively flat and brittle.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: 7794643
• MDR Text Key: 117571999
• Report Number: 1030489-2018-01153
• 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
• Report Date: 01/07/2019

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: NM12E003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2018
• Initial Date FDA Received: 08/17/2018
• Supplement Dates Manufacturer Received: 12/12/2018
• Supplement Dates FDA Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• 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