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 Pain (1994); Weakness (2145); Stenosis (2263)

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) 2013 the patient underwent anterior cervical discectomy and fusion- extrapharangeal anterolateral approach.Levels implanted: c4-c5, c5-c6, c6-c7.Preoperative diagnosis: degenerative disc disease.Following mentioned are the adverse events occurred: ae#1: event date: (b)(6) 2014 primary diagnosis: weakness in right hand followed overtime by pain in right deltoid, for past few months.Hospitalizations: date of admission: (b)(6) 2014; discharge date: (b)(6) 2014 other actions: the patient underwent hemilaminectomies and foraminotomy c7-t1 for nerve decompression, tolerated without adversity.Relatedness: not related severity: severe outcome: unknown ae#2: event date: (b)(6) 2015 primary diagnosis: weakness in fingers of right hand with global <(>&<)> progressive loss of function in right hand hospitalizations: date of admission: (b)(6) 2014; discharge date: (b)(6) 2014 other actions: the patient underwent acdf c7-t1 at outside hospital.Relatedness: not related severity: severe outcome: unknown ae#3: event date: (b)(6) 2015 primary diagnosis: lost his voice hospitalizations: date of admission: (b)(6) 2014; discharge date: (b)(6) 2014 other actions: the patient referred self to local ent specialist who told that patient had vocal cord paralysis.Patient was scheduled to collagen injection.Relatedness: not related severity: moderate outcome: unknown diagnostic test: a) lateral cervical spine radiographs: (b)(6) 2015; results: normal.Mri without contrast cervical spine: (b)(6) 2014; results: abnormal, right foraminal encroachment/possible disc herniation, c7-t1.Mri without contrast cervical spine: (b)(6) 2014: results: abnormal, right foraminal stenosis, c7-t1.Electromyelograph with nerve conduction studies: (b)(6) 2014; results: abnormal, worsening c8 radiculopathy.

Event Description

It was reported that ae#2: event occurrence: (b)(6) 2015 primary diagnosis: progressive c8 radiculopathy, recalcitrant to nonoperative therapy.Diagnostic test: lateral cervical spine radiographs: (b)(6) 2015; results: normal.Mri without contrast cervical spine: (b)(6) 2014; results: abnormal, right foraminal encroachment/possible disc herniation, c7-t1.Mri without contrast cervical spine: (b)(6) 2014: results: abnormal, right foraminal stenosis, c7-t1.Electromyelograph with nerve conduction studies: (b)(6) 2014; results: abnormal, worsening c8 radiculopathy.Hospitalizations: date of admission: (b)(6) 2014; discharge date: (b)(6) 2014.Length of hospitalization: greater than 24 hours.Surgical treatments: no.Othet actions: the patient underwent acdf c7-t1 at outside hospital.Relatedness: not related severity: severe; sae: yes; outcome: unknown ae#3: primary diagnosis (modified): vocal cord paralysis hospitalizations: date of admission: (b)(6) 2014; discharge date: (b)(6) 2014, length of hospitalization: greater than 24 hours.Surgical treatments: no.Relatedness: undetermined sae: no.

Event Description

It was reported that on ae#3: primary diagnosis (modified): vocal cord paralysis hospitalizations: date of admission: on (b)(6) 2014; discharge date: on (b)(6) 2014, length of hospitalization: greater than 24 hours.Surgical treatments: no.Relatedness: undetermined sae: no.

Manufacturer Narrative

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

• 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: 6029582
• MDR Text Key: 57421800
• Report Number: 1030489-2016-02895
• 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: study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• 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
• Date Manufacturer Received: 11/15/2016
• 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
• Patient Age: 67 YR
• Patient Weight: 91