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

Catalog Number 7510200

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Tingling (2171); Injury (2348)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2011, the patient underwent spine fusion surgery on the lumbar region of the spine from vertebrae l4 to l5.The patient was implanted with rhbmp-2/acs which was applied from transforaminal approach and was placed outside the cage (in the disk space).Post-operatively, patient complained of progressively worsening pain in low back and associated radiculopathy.Also patient continued to experience severe and unrelenting pain in the low back that radiated to legs, with swelling, numbness and tingling in legs.The patient experienced difficulty in standing and walking and required the use of the cane to assist in ambulation.The injuries prevented the patient from practicing the activities of daily life.The patient allegedly suffered serious and permanent injuries.

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.

Manufacturer Narrative

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

Event Description

The patient was pre-operatively diagnosed with l4-5 unstable spondylolisthesis with left-sided lateral recess stenosis and underwent the following procedure: minimally invasive decompression of left l4-5 and fusion of l4-5 with interbody fusion device, pedicle screws, neuro monitoring, and rhbmp2.As per the op notes the screws were placed at l4 and l5 using a burr to perforate posteriorly.The l4-l5 level was identified and a complete l4-l5 facetectomy was performed, foraminotomy and decompression performed on that level, completely decompressing the l4 and l5 nerve roots.An 11 x 22 trial was placed, and then with the 11 x 22 trial in place, distraction was carried out across the contralateral side, on the right side, with a distraction rod.This was locked into position.The 11 x 22 trial was removed and some rhbmp-2/acs was packed in the front of the disk space.Absorbable powder was used to pack some mulched autograft bone in the front and an 11 x 22 cage was packed with rhbmp-2/acs and pounded into position.This was guided by ap and lateral c-arm as well.No complications were reported.

• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4892008
• MDR Text Key: 18389951
• Report Number: 1030489-2015-01364
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2014
• Device Catalogue Number: 7510200
• Device Lot Number: M111064AAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/18/2011
• 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