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 Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Burning Sensation (2146); Cramp(s) (2193); Numbness (2415); Ambulation Difficulties (2544)

Event Date 03/01/2007

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.

Event Description

It was reported that on (b)(6) 2007, the patient underwent a spinal fusion surgery on the lumbar region of his spine from vertebrae l4 to l5.Reportedly, during the surgery, rhbmp-2/acs was used in the patient.As reported, the patient's post-operative period had been marked by a period of improvement, followed by increasing low back pain, eventual onset of pain and radiculopathy into his buttocks and thighs, and intermittent numbness and burning sensations in his feet.The patient continues to experience extreme back pain, with pain radiating down to his buttocks, legs and feet; muscle spasms and cramping in his legs and feet; and occasional, sharp upper back pain.Patient experiences difficulty sitting and standing, and cannot walk extended distances.These serious injuries prevent patient from practicing and enjoying the activities of daily life that patient enjoyed pre-operatively.

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 presented with the following pre-op diagnoses: degenerative disk disease involving l5-s1.He underwent the following procedures: anterior retroperitoneal exposure of l5-s1 with mobilization of the iliac vessels and then subsequent closure.Diskectomy of l5-s1.Anterior interbody fusion of l5-s1 with femoral bone graft and bone morphogenic protein.Application of plate and screws.Anterior instrumentation with plate and screws - size 41 millimeter plate with four size 23 millimeter screws.Placement of interbody allograft bone ring with bmp.As per the operative notes,¿ the diskectomy, fusion application of plate and screws was done.After his procedures, the final ap and lateral views were taken.These showed the graft, plate and screws to be in good position.The retractors were then very gently removed, allowing return of the structures into their respective places.¿ no intra-operative 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5549667
• MDR Text Key: 41937252
• Report Number: 1030489-2016-00959
• 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: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2009
• Device Catalogue Number: 7510400
• Device Lot Number: M110604AAG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/06/2016
• Supplement Dates Manufacturer Received: 03/10/2016; 03/26/2018
• Supplement Dates FDA Received: 09/20/2017; 04/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/12/2007
• 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
• Patient Age: 34 YR