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

Catalog Number 7510600

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

Patient Problems Incontinence (1928); Nerve Damage (1979); 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 manufacturers 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.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.

Event Description

It was reported that on (b)(6) 2003, the patient underwent fusion surgery on the lumbar region at levels l3-l4 wherein rhbmp-2/acs was implanted in the disc space.Post-op, the patient experienced increased low back, left buttock and left leg pain.The patient underwent a revision surgery on (b)(6) 2004.Reportedly, the patient continued to experience chronic and extreme back pain, radiating to her hips, and numbness, tingling and swelling in her left leg down to her foot.She experienced difficulty sitting,standing and walking, and required a cane for assistance in ambulation.The patient also suffered from nerve damage and bladder incontinence.

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2003 the patient was pre-operatively diagnosed with discogenic low back pain and underwent following procedures: anterior decompression l3-4 with removal of central disc herniation.Anterior fusion l3-4 with a "dial"(18x22 millimeter), and crushed cancellous allograft with large kit rhbmp-2/acs.Posterior facet fusion l3-4.Posterior stabilization with spinal instrumentation l3-4.As per the operative notes: "once decompression of the spinal canal was complete, we dilated the space and placed an oblique reamer for a bone dial and reamed to 29 millimeter and tapped appropriately.We removed this and placed a bed of crushed cancellous allograft followed by two rhbmp-2 sponges and one sponge within the bone dial itself.The bone dial was countersunk approximately three to four millimeters.Then, medial to the dial, we placed additional rhbmp-2 sponge, crushed cancellous allograft and further rhbmp-2 sponges and crushed cancellous allograft.This gave an excellent fill.".

• 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: 5562394
• MDR Text Key: 42145263
• Report Number: 1030489-2016-01028
• 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: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510600
• Device Lot Number: MC111001C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/05/2017
• 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): Required Intervention