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); Pain (1994); Loss of Range of Motion (2032); Inadequate Pain Relief (2388); Numbness (2415); Neck Pain (2433)

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.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on (b)(6) 2012, patient underwent spine fusion surgery on the cervical region from vertebrae c4 to c7.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.Allegedly, "patient's post-operative period was marked by a period of improvement, followed by progressively increasing neck and shoulder pain, headaches, and difficulty swallowing.Patient continues to experience chronic pain in her neck, shoulders, arms, and upper back, and numbness in her right hand.Patient was experiencing headaches, limited range of motion in her neck, and difficulty swallowing.These serious injuries prevent patient from practicing and enjoying the activities of daily life that she enjoyed pre-operatively'.

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.

Manufacturer Narrative

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

Event Description

It was reported that the patient presented with following pre-op diagnosis: c4 to c7 cervical stenosis and cervical radiculopathy.The patient underwent following procedures: c1-c5, c5-c6 and c6-c7 anterior cervical diskectomy and fusion with machined allograft interbody spacers and anterior instrumentation c4 to c7.As per operative notes, ¿an 8¿mm lordotic mechanized allograft cortical interbody spacer was filled with a fix of a sponge of bmp and impacted in the disc space achieving a good fit.At c5-c6 , the exact same decompression, discectomy and interbody grafting were performed as at , c4-c5 except at this level the allograft was 9mm in height.¿ 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6208011
• MDR Text Key: 63359215
• Report Number: 1030489-2016-03576
• 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: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 7510050
• Device Lot Number: M111116AAK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/17/2012
• 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