MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC SHILLA GROWTH GUIDANCE SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 04/01/2020

Event Type  Death  

Manufacturer Narrative

Procode: pgm: growing rod system the following devices were used in the surgery: 1.Product id: 7674425, qty: 2.2.Product id: 7673425, qty: 4.3.Product id: 7673025, qty: 2.4.Product id: 7673525, qty: 2.5.Product id: 7674025, qty: 4.6.Product id: 7674500, qty: 2.7.Product id: 7674501, qty: 5.8.Product id: 7674502, qty: 2.Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.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 presented with scoliosis; and underwent growth guidance system procedure at t6-l4.Intra-op, the patient died due to bleeding.All screws, temporary rods, and sets screws had been placed prior to the event.Bleeding occurred during resection of the bone.Blood products were given as a result of this event.A code was called and resuscitation efforts were initiated.The patient died after all the efforts failed.

• Brand Name: SHILLA GROWTH GUIDANCE SYSTEM
• 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: 10014572
• MDR Text Key: 189570943
• Report Number: 1030489-2020-00487
• Device Sequence Number: 1
• Product Code: PGM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Death
• Patient Age: 5 YR