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 Dysphagia/ Odynophagia (1815); Headache (1880); Nausea (1970); Swelling (2091); Vomiting (2144); Weakness (2145); Tingling (2171); Numbness (2415)

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

Type of procedure (including approach): anterior cervical discectomy and fusion (acdf)-extrapharyngeal anterolateral initial diagnosis/medical history acdf for treatment of degenerative disc disease (ddd), mild elevation of prothrombin time with normal inr, open heart surgery(vsd repair) at age 2 years levels: c5-c6, c6-c7 it was reported that rhbmp2 was used in the patient on (b)(6) 2010 at a single cervical level.On (b)(6) 2010, patient reported pain.On (b)(6) 2010, patient reported sore throat.On (b)(6) 2010, patient reported nausea/vomiting.On (b)(6) 2010, patient reported incisional swelling.On (b)(6) 2010, patient reported paresthesias (numbness, tingling, weakness) affecting left upper extremities and fingers.On (b)(6) 2010, patient reported dysphagia, vocal cord weakness, constipation, migraine headache, pain.Onset (b)(6) 2010, patient reported focal paresthesias(numbness, tingling, weakness).On (b)(6) 2010, patient reported minimal residual symptomatology.

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: 5942181
• MDR Text Key: 54396891
• Report Number: 1030489-2016-02524
• 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: health professional,study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2010
• Device Catalogue Number: 7510050
• Device Lot Number: M110901AAG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/29/2009
• 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: 32 YR
• Patient Weight: 88