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

Catalog Number 7510800

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

Patient Problems Muscle Spasm(s) (1966); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2015, patient was admitted to the facility where the surgeon performed spine fusion surgery using rhbmp2 on the thoracolumbar region of his spine from vertebrae t8 to l2.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was placed outside a cage (i.E., over the posterior elements).Post-op, " patient continues to experience constant mid and upper back pain, with pain radiating throughout his entire back and down his legs, numbness throughout his body, muscle spasms and swelling on his right side, and muscle spasms in his right arm and hand.Patient experiences difficulty sitting, standing and walking, and must use a walker to assist in ambulation.".

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient was pre-operatively diagnosed with thoracic spinal osteomyelitis, status post t11 vertebrectomy and anterior spinal fusion and underwent the following procedures: 1) posterior spinal fusion, t8-l2.2) segmental pedicle screw instrumentation, t8-l2.3) local autograft bone.As per op-notes,¿ we then performed a posterior arthrodesis.We decorticated posterior elements at all levels from t8 down to l2.This included the lamina, cartilaginous surface of the facet joints and transverse processes.We laid strips of rhbmp-2/acs over decorticated posterior elements as well as local bone graft obtained from laminectomy which was morselized in a bone mill as well as bone matrix.This completed the posterior arthrodesis from t8 to l2.¿ the patient tolerated the procedure well without any intraoperative complications.(b)(6)2015: the patient was discharged from the facility.

• Brand Name: INFUSE BONE GRAFT
• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6019987
• MDR Text Key: 57053065
• Report Number: 1030489-2016-02856
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510800
• Device Lot Number: M111408AA4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2018
• 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