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 05/20/2019

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 was pre-operatively diagnosed with kyphosis; and underwent l2-l3 posterior lumbar interbody fusion, l4-l5 transforaminal lumbar interbody fusion and l4 pedicle subtraction osteotomy.Intra-op, after hammering the first cage at l4-l5, it was noticed that the claw part of the inserter remained in the cage.This was found in the image after the placement of the cage.The physician tried to remove the broken part by suction of blood.When performing suction, the broken part could not be found in the patient¿s body, and the broken part was found missing.It could not be determined if the broken fragment of the instrument remained inside the patient or not.No patient complications were reported.

Manufacturer Narrative

Product analysis: visual exam and microscopic exam show that the upper tab of the instrument is completely sheared off and the threaded inner shaft is missing.The broken piece was not returned for the analysis.This is consistent with bend stress overload.The hardness of the instrument is within print specification.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: 8703552
• MDR Text Key: 148157008
• Report Number: 1030489-2019-00630
• 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: 08/14/2019

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: NM12A017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 08/07/2019
• Supplement Dates FDA Received: 08/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• 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
• Patient Outcome(s): Other