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

Catalog Number 7510400

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

Patient Problems Neuropathy (1983); Pain (1994); Swelling (2091); 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.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on (b)(6) 2015, patient underwent posterior lumbar interbody fusion and posterolateral fusion from vertebrae l5 to s1.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was placed outside a cage (i.E., over the transverse processes).Allegedly, "patient's post-operative period was marked by a period of improvement, followed by progressively worsening low back pain, with radiating pain, swelling and numbness in his legs.The patient continues to experience constant pain in his low back, swelling in his left hip, numbness in his lower extremities, bladder/bowel dysfunction, and sexual issues.The patient requires occasional use of a cane to assist in ambulation.".

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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 preoperatively diagnosed with right leg pain, secondary to far lateral recess stenosis secondary to spondylolysis at l5-s1 and underwent the following procedures: gill decompressive laminectomy, posterior lumbar interbody fusion l5-s1 with insertion of two cages right-sided posterolateral fusion at l5-s1 and internal fixation with percutaneous pedicle screws at l5-s1 on the right.Post-op diagnosis revealed that the patient had a far lateral right-sided l5-s1 disk herniation.As per the op notes, "when doctor performed this disk herniation a large amount of far lateral disk herniation was removed from the right nerve foramen, thus decompressing the right l5 nerve root.The l5 interspace was then distracted and prepared for the fusion and two 11 x 30 mm cages were then placed in the disk space under distraction.Doctor supplemented the cages with rhbmp-2/acs and placed locally harvested autograft between the cages.¿ the patient tolerated the procedure well without any intraoperative complication.

• 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: 6208008
• MDR Text Key: 63358552
• Report Number: 1030489-2016-03572
• 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: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 7510400
• Device Lot Number: M111502AA4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/12/2015
• 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