MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INDUCTOS; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

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

Patient Problems Fever (1858); Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable medical records or imaging studies were returned nor provided for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported in the literature titled ¿treatment of pediatric spinal deformity with use of recombinant human bone morphogenetic protein-2¿ that 13 children patients (4 females and 9 males) with a mean age of 11.2 years underwent spinal rhbmp-2 surgery.Rhbmp-2 was used in both primary and revision surgery in patients.Post-op, complications occurred where 3 patients had an increased body temperature and 1 had prolonged wound and in one of these patients an extensive postoperative hematoma occurred.In one case revision surgery due to the development of an extensive hematoma was necessary after rhbmp-2 application in this study.This complication was thought to be due to the use of rhbmp-2.

• Brand Name: INDUCTOS
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• 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: 8207429
• MDR Text Key: 131761540
• Report Number: 1030489-2019-01722
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 01/01/2019
• Was Device Evaluated by Manufacturer?: No
• 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): Other; Required Intervention