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

Catalog Number 7510100

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

Patient Problems Neuropathy (1983); Pain (1994); Swelling (2091); Tingling (2171); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Products from multiple manufacturer / multiple products were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on (b)(6) 2012, the patient underwent transforaminal lumbar interbody fusion and posterolateral fusion surgery on the lumbar region of his spine from vertebrae l5 to s1.Reportedly, patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was placed outside a cage, i.E., in the disc space and posterolateral gutters.Allegedly, the patient's pos t-operative period was marked by "a period of improvement followed by increasingly severe mid and low back pain, with pain and radiculopathy in his legs".Patient continues to experience "chronic mid to lower back pain, with pain radiating down his legs and up to his shoulders, swelling in his hands and body, and numbness and tingling in his feet.Patient suffers from retrograde ejaculation, erectile dysfunction, and bladder dysfunction.Patient experiences difficulty sitting, standing and walking, and requires a cane 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

It was reported that the patient was pre-operatively diagnosed with degenerative disc disease, l5-s1, with right greater than left radicular pain and underwent the following procedures: transforaminal lateral interbody fusion, l5-s1, right; posterior lateral fusion, l5-s1, right; pedicle screw instrumentation using minimally invasive approach, l5-s1.As per op-notes, "the disk material was thoroughly cleaned.After this was accomplished, then a pledget of bone morphogenic protein was then packed into the disk space using 1/2 of an extra-small size and then morcellated bone fragments were packed into the disk space.Following this, a 10 x 11 x 25 mm peek cage was then placed into the disk space, carefully protecting the l5 and 51 nerve roots.This was done under fluoroscopic guidance.The peek cage was packed with bone followed by a small wedge of bone morphogenic protein.¿ the patient tolerated the procedure well without any intraoperative complications.

• 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: 6013395
• MDR Text Key: 56917132
• Report Number: 1030489-2016-02814
• 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: 04/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 7510100
• Device Lot Number: M111116AAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2012
• 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