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 Ossification (1428); Edema (1820); Neuropathy (1983); Pain (1994); Burning Sensation (2146); 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.

Event Description

It was reported that on (b)(6) 2012, the patient underwent transforaminal lumbar interbody fusion surgery on the lumbar region of her spine from vertebrae l3 to l5.Reportedly, patient was implanted with rhbmp-2/acs in this surgery.Allegedly, the patient's post-o perative period was marked by "a period of improvement followed by increasing low back pain, bilateral hip pain, and burning pain in her right hip and leg".The patient underwent revision surgery on (b)(6) 2013, (b)(6) 2014 and (b)(6) 2016 due to bony overgrowth.Patient continues to experience "chronic low back pain, with pain radiating to her hips and right leg, numbness in her right leg, and localized edema.Patient experiences difficulty sitting, standing and walking, and requires use of a walker for ambulation outside of her home.Patient also suffers from gastrointestinal and 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) 2012: the patient presented with following pre-operative diagnosis: lumbago refractory to conservative therapy secondary to l4-l5 and l5-s1 disc disease and spondylosis.The patient underwent the following procedures: epidurography, interpretation of fluoroscopy, followed by instillation of 2 mg of astramorph; minimally invasive transforaminal lumbar interbody fusion (tlif) , l3-4, l4-5; posterior non-segmental instrumentation with percutaneous pedicle screws and peek (or titanium) rod, bilateral, 3-6 vertebral segments, bilateral; application of biomechanical device ¿ placement of peek cage in (segment) disc space, l3-4, l4-5; microdissection.As per the operative notes, ¿rotate covers were used on the endplate up to 14 mm in height.Eventually, a 25 x 14-mm cage was filled with bone morphogenetic protein/rhbmp-2.This was then covered with autograft and novabone which was packed around 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: 6019946
• MDR Text Key: 57053167
• Report Number: 1030489-2016-02846
• 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: 06/12/2018

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: 09/19/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: 09/19/2016; 05/14/2018
• Supplement Dates FDA Received: 09/25/2017; 06/12/2018
• 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): Required Intervention