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 Ossification (1428); Incontinence (1928); Weakness (2145); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Literature citation: elias elias , zeina nasser, lona winegan , terence verla, ibrahim omeis; "bone morphogenetic proteins usage in anterior lumbar inter-body fusion: what else can go wrong?" 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.Although it is unknown if the device caused or contributed to the reported event, we are filing this report for notification purposes.

Event Description

It was reported in a publication entitled ¿bone morphogenetic proteins usage in anterior lumbar inter-body fusion: what else can go wrong?¿ that the patient underwent a surgery using rhbmp-2.Post-op, patient suffered from lower extremity numbness <(>&<)> weakness with bilateral foot drop (later inability to stand / ambulate unsupported), grade i anterolisthesis, intra-dural bone growth, incontinence, lower extremity and perineal loss of sensation from l4 level (latter requiring catherization to empty bladder).Two revision surgeries (at 2 years and 5 years post index-surgery) were performed to relieve the complaints.

• 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: 7181536
• MDR Text Key: 96933359
• Report Number: 1030489-2018-00051
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• 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
• Date Manufacturer Received: 12/20/2017
• 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