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 Neuropathy (1983); Pain (1994); 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.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) 2011, the patient underwent anterior lumbar interbody fusion surgery on the lumbar region of his spine from vertebrae l4 to s1.Allegedly, patient was implanted with rhbmp-2/acs in this surgery.Reportedly, "patient's post-operative period was marked by a period of improvement, followed by increasingly severe pain in his lower back, with pain radiating all the way down to his calf and foot." the patient underwent a revision surgery on (b)(6) 2015 due to severe pain and symptoms.Reportedly, "patient continues to experience constant and chronic middle to lower back pain, with pain radiating down his left leg to his foot, and numbness in his left foot.He experiences difficulty sitting, standing and walking for extended periods, and difficulty sleeping due to pain.Patient also suffers from bowel dysfunction.".

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 on (b)(6) 2011, the patient presented with the following pre-op diagnosis: l4-5 and ls-s1 discogenic back pain and degenerative discs disease.Patient underwent following procedures: anterior retroperitoneal exposure of l4-5 and l5-s1 and subsequent closure; complete discectomy of l4-5 and ls-s1; anterior lumbar interbody fusion of l5-s1 and l4-5 with two cages each as well as rhbmp-2 and bone graft were prepared.As per operative notes,¿ the discectomy was done over and above the simple block discectomy decompressing back to the spinal canal, addressing redundant annulus and the obvious disc herniation.Rhbmp-2, allograft nonstructural, and cages were applied using standard protocols and the bmp was allowed to cure.The appropriate sized threaded cages were applied and countersunk appropriately to get adequate distraction our goal being an indirect decompression and opening the foramen through the anterior approach.The discectomy was done over and above the simple block discectomy decompressing back to the spinal canal addressing redundant annulus and obvious disc herniation.Rhbmp-2 and allograft, cages were allowed to cure and after that decompression, the threaded cages were applied using standard techniques.¿ 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: 6025376
• MDR Text Key: 57250304
• Report Number: 1030489-2016-02881
• 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: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2014
• Device Catalogue Number: 7510600
• Device Lot Number: M111059AAJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2011
• 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): Required Intervention