MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INDUCTOS

Catalog Number 751090001

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

Patient Problem Failure of Implant (1924)

Event Type  Injury  

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

It was reported that on unknown date, the patient was implanted with 12mg 1.5mg/ml rhbmp-2/acs in conjunction with demineralized bone matrix strips.The graft was implanted at posterior lateral side in lumbar spine.On an unknown date, post-op, patient underwent a revision/extension of scoliosis correction after pseudoarthrosis.

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog # 7510800, pma # p000058 and udi # (b)(4) was cleared in the united states.If information is provided in the future, a supplemental report will be issued.

Event Description

The surgery, when the reported product was implanted, was about 18 months ago.Spinal screws, rods, cage, construct that were implanted in this surgery, belonged to another manufacturer.Revision surgery was performed on (b)(6) 2020.Patient current health condition were not known yet.

• Brand Name: INDUCTOS
• 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: 9536233
• MDR Text Key: 173673177
• Report Number: 1030489-2019-01512
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: SEE H10
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 751090001
• Device Lot Number: 4504152844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR