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); Weakness (2145); Tingling (2171); Anxiety (2328); Depression (2361); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Weight Changes (2607)

Event Type  Injury  

Manufacturer Narrative

(b)(4) (persisting back pain).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.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) 2004, the patient underwent anterior lumbar interbody fusion surgery on the lumbar region of his spine from vertebrae l4 to s1.Reportedly, "the rhbmp-2 collagen sponge was used to fuse more than one level of the spine".Post-op patient allegedly had "increasingly severe low back pain, with pain radiating down his legs, and associated lower extremity weakness, numbness and tingling ".Reportedly the patient "continues to experience constant and extreme lower back pain, with pain radiating to his legs and feet, severe left pain, and numbness and tingling down both legs and into his feet.He experiences difficulty sitting, standing and sleeping due to pain, must constantly change positions and cannot walk long distances.He also suffers from bladder and bowel issues, sexual issues, depression and anxiety, and extreme weight loss due to lost of appetite due to pain.He requires occasional use of a cane for assistance in ambulation".

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) 2004: the patient was pre-operatively diagnosed with central disc bulge and discogenic back pain l4-5 and l5-s1 and underwent the following procedures: a 360 degree fusion at l4-5 and l5-s1, anterior lumbar fusion at l4-5 and l5-s1.Posterior pedicle screws l4, l5 and s1 with minimally invasive sextant procedure.As per operative notes,¿ the anterior annulus was incised.Discectomy was carried out with curettes and rongeurs.The disc space was curetted.A double-barrel distractor was placed and then reaming was carried out and finally placement of 16 x 23 mm cages.After four cages had been placed, bone morphogenic protein previously mixed and collagen sponges were placed in the cages, two sponges in each cage.Surgicel was placed over the anterior aspect of the spine.¿ the patient tolerated the procedure well without any intraoperative complications.

• 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: 6020019
• MDR Text Key: 57055760
• Report Number: 1030489-2016-02860
• 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: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510400
• Device Lot Number: M111008AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2018
• 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): Other