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 Nausea (1970); Pain (1994); Swelling (2091); Tingling (2171); Sore Throat (2396); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517)

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 per a clinical study that on (b)(6) 2010, the patient underwent anterior cervical discectomy and fusion (acdf).The patient was implanted with rhbmp-2/acs in this surgery.Initial diagnosis: acdf for treatment of degenerative disc disease.Type of procedure: anterior cervical discectomy and fusion (acdf) - retropharyngeal anterolateral approach levels of treatment: c4-5, c5-6 onset (b)(6) 2010 - paresthesia (tingling), both hands (in recovery room).Onset (b)(6) 2010 - sore throat.Onset (b)(6) 2010 - patient feels like blood sugar is dropping (nos).Onset (b)(6) 2010 - patient feels like blood sugar is dropping (nos).Onset (b)(6) 2010 - pain, mild to moderate (nos) (patient in recovery room s/p acdf.Onset (b)(6) 2010 - nausea.Onset (b)(6) 2010 - incisional swelling.Onset (b)(6) 2010 - difficulty sleeping.Onset (b)(6) 2010 - pain, mild to moderate, in neck, shoulders, left arm.Onset (b)(6) 2010.Feels "deconditioned" on an unknown date the patient reported pain, scapula, occasional.Onset (b)(6) 2010 - dysesthesia, paresthesias (numbness, tingling) of left arm, shoulder, scapula.

Event Description

It was reported that patient demographics: age at the time of index surgery: (b)(6).Exam date: (b)(6) 2016 adverse event 1-onset (b)(6) 2009- pain at surgical site.Relatedness: surgical procedure associated.Severity: mild; sae: no.Outcome: resolved, resolution date: (b)(6) 2009.Adverse event 2-onset (b)(6) 2009- paresthesia (numbness), bilateral upper extremities and both feet other actions: nurse counseled patient regarding activity restrictions at this stage of surgical recovery (post-op day #10).Relatedness: not related.Severity: mild; sae: no.Outcome: resolved, resolution date: (b)(6) 2010.Adverse event 3-onset (b)(6) 2010- history of dysphagia post-operatively relatedness: surgical procedure associated.Severity: mild; sae: no.Outcome: resolved, resolution date: (b)(6) 2010.Adverse event 4: onset (b)(6) 2010- paresthesia (numbness) bilaterally in cervical 6-7 nerve root distribution.Relatedness: not related.Severity: mild; sae: no.Outcome: resolved, resolution date: (b)(6) 2010.

Event Description

It was reported that ae#1: relatedness: not related ae#2: other actions: reassurance and other nonpharmacologic comfort measures provided by nurse and family relatedness: surgical procedure associated ae#3: relatedness: surgical procedure associated ae#11: relatedness: not related ae#12: relatedness: undetermined outcome: unknown.

Event Description

It was reported that on ae#9: primary diagnosis (modified): neck pain after acdf surgery.Surgical treatments: no other actions: continued on current pain medications; given activity precautions, walking program; next follow up scheduled.Ae#14: event occurrence: (b)(6) 2010 primary diagnosis: bilateral shoulder pain after acdf surgery surgical treatments: no other actions: continued on current analgesics; given activity precautions, walking program; next post-op follow up scheduled.Relatedness: surgical procedure associated severity: mild; sae: no outcome: resolved, resolution date:(b)(6) 2010.Ae#15: event occurrence: (b)(6) 2010 primary diagnosis: left arm pain status post acdf surgery surgical treatments: no other actions: continued on current analgesics; given activity precautions, walking program; next post-op follow up scheduled.Relatedness: surgical procedure associated severity: mild; sae: no outcome: resolved, resolution date: (b)(6) 2010.

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: 5951792
• MDR Text Key: 54749152
• Report Number: 1030489-2016-02548
• 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,Followup
• Report Date: 11/15/2016

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
• Device Expiration Date: 11/30/2010
• Device Catalogue Number: 7510050
• Device Lot Number: M110906AAF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 11/15/2016
• Supplement Dates FDA Received: 10/07/2016; 11/16/2016; 12/07/2016; 09/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/20/2009
• 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: 63 YR
• Patient Weight: 79