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

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

Patient Problems Dyspnea (1816); Neuropathy (1983); Pain (1994); Weakness (2145); Neck Pain (2433); 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.

Event Description

It was reported that on (b)(6) 2012, patient underwent anterior cervical diskectomy and fusion from vertebrae c5 to c7.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.Allegedly, "patient's post-operative period was marked by a period of improvement, followed by increasingly severe neck pain, with radiculopathy and paresthesias in her upper extremities.The patient continues to experience chronic neck pain, bilateral shoulder pain, weakness in her arms and hands, and symptoms of cervical myelopathy.Patient experiences difficulty standing and walking and requires a cane for assistance due to loss of balance.Patient also suffers breathing difficulties and bladder 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.

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2012, the patient presented with following pre-op diagnosis: c5-6 and c6-7 cervical stenosis and cervical radiculopathy.The patient underwent following procedures: c5-c6 and c6-c7 anterior cervical discectomy and fusion with machined allograft and interbody spacer and anterior instrumentation.As per operative notes,¿ the wound was irrigated.An 8 mm lordotic machined allograft cortical interbody spacer filled with a quarter sponge of rhbmp-2 was then impacted into the disc space achieving a good fit.Attention was then turned to the c6-c7 level and the exact same decompression, discectomy and interbody grafting was then performed at c6-c7 as of c5-c6.Once interbody work was completed, local bone from the approach was packed anterior to the grafts.Blue fibrin glue was used to seal the disc space.¿ 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: 6207983
• MDR Text Key: 63358683
• Report Number: 1030489-2016-03551
• 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,Followup
• Report Date: 10/04/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: 12/05/2016; 06/11/2018; 08/08/2018
• Supplement Dates FDA Received: 09/27/2017; 07/11/2018; 10/03/2018
• 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