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

Catalog Number 7510050

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

Patient Problems Apnea (1720); Fatigue (1849); Hypoxia (1918); Pain (1994); Weakness (2145); Tingling (2171); Stenosis (2263); Anxiety (2328); Injury (2348); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517)

Event Type  Injury  

Event Description

It was reported that the patient underwent anterior fusion c3-c4 using rhbmp-2/acs.Post-op, the patient developed increasing low back pain, cramping, associated radiculopathy and numbness in her right leg and foot, and neck pain.The patient continues to experience radiating pain in her low back along with pain, numbness, tingling, and weakness in her right leg.She continues to have severe neck pain with accompanying and debilitating headaches.These serious injuries prevent patient from practicing and enjoying the activities of daily life that she enjoyed pre-operatively.

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.

Manufacturer Narrative

(b)(4).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) 2011, the patient presented with pre-op diagnosis of c3-4 dynamic instability with stenosis , degenerative disk disease.The patient underwent following procedure: anterior cervical discectomy , decompression and fusion c3-4 using bmp combined with allograft , spine plate instrumentation.Per op-notes, ¿¿ this was packed with a small piece of bmp soaked sponge combined with bone graft.Local bone graft was obtained from endplate preparation with the bur.Additional bone graft was placed in the posterior disk space.Autogenous graft was combined with a small piece of bmp soaked sponge.¿ on (b)(6) 2011: patient presented for follow-up after cervical fusion.Diagnosis: status post cervical spine fusion c3-4; prior cervical spine fusion c5-6.Chronic narcotic pain medication.Patient underwent x-ray of cervical spine.Impression: c3-c4 and c5-c6 plate and interbody fusion intact.On (b)(6) 2011, the patient presented for follow up after cervical spine fusion.The patient was diagnosed for the following: status post cervical spine fusion c3-4 ; prior cervical spine fusion c5-6; chronic narcotic pain medication.On (b)(6) 2011: patient presented for pain management.Assessment: degenerative joint disease (djd) of lumbar spine.Degenerative joint disease of cervical spine.On (b)(6) 2011: patient presented with complaint of neck and low back pain.Diagnoses: acute lumbar strain; chronic pain syndrome; chronic opioid dependency.On (b)(6) 2011: patient presented for pain recheck and sleep apnea.Assessment: excessive somnolence disorder.On (b)(6) 2011: patient underwent polysomnogram.Impression: fibromyalgia; poor sleep hygiene; tobacco abuse; nocturnal oxy hemoglobin desaturation.Ryle out any underlying cardio pulmonary disease.On (b)(6) 2011: patient presented with degeneration and bilateral stenosis at the lateral recess above that at l4-5.Patient also had degeneration at l2-3 and l3-4 with some mild bulging.In addition to low back pain patient also had increased neck pain after a near car accident.On (b)(6) 2011, (b)(6) 2012: patient presented with low back pain and neck pain.On (b)(6) 2011: patient presented with low oxygen levels.Assessment: hypoxia.Patient also underwent chest x-ray.Impression: negative chest.Cervical fixation hardware.Patient underwent dexa, axial skeleton scan.Impression: normal bone mineral density.Patient underwent mammogram screening.Impression: implants appear intact.No evidence of malignancy.On (b)(6) 2012: patient presented for pain recheck.Assessment: low back pain.On (b)(6) 2012: patient presented with complaint of chronic pain and anxiety.And, also with pft results and x-ray results.Impressions: insomnia; tobacco abuse.On (b)(6) 2012: patient presented with complaint of fatigue and back pain.Assessment: low back pain and neck pain.On (b)(6) 2012: patient presented with cervical, thoracic, and lumbar spinal conditions.On (b)(6) 2012: patient presented to discuss narcotic taper prior to cervical spine surgery.On (b)(6) 2012: patient presented with complaint of chronic pain and anxiety.On (b)(6) 2012: patient presented for medication check and complained of back pain.Assessment: low back pain, neck pain, cervicalgia.On (b)(6) 2012: patient presented with chronic pain.On (b)(6) 2012: patient presented with cervical, thoracic, and lumbar spinal conditions and shoulder pain.On (b)(6) 2012: patient underwent mri of lumbar spine.Impressions: left lateral recess stenosis at l4-5 question left l5 left l4 symptoms; asymmetric protruding disc to the left at l2-3 question left l3 symptoms.

Manufacturer Narrative

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) 2012: as per the billing records, the patient presented for an office visit.

• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4555025
• MDR Text Key: 17334999
• Report Number: 1030489-2015-00378
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2012
• Device Catalogue Number: 7510050
• Device Lot Number: M111058AAK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2011
• 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): Other
• Patient Weight: 103