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 Problem Dysphagia/ Odynophagia (1815)

Event Date 09/01/2014

Event Type  Injury  

Event Description

It was reported that the records of 30 consecutive patients who underwent same-day combined anterior-posterior cervical spine surgery were reviewed.The presence of dysphagia was assessed by a formalized screening protocol using history/clinical presentation and a bedside swallowing test, followed by formal evaluation by speech and language pathologists and/or fiberoptic endoscopic evaluation of swallowing/modified barium swallow when necessary.Recombinant human bmp-2 was used in 26 cases (86.7%), with a mean dose of 11.1 mg used per case (range 8.4¿24 mg).For 25 of these cases, rhbmp-2 was only used for the posterior procedure.One patient presented with metastasis.The patient underwent c4/4 anterior-posterior fusion.Post-op, the patient developed dysphagia diagnosed by a certified speech and language pathologist.Modified barium swallow demonstrated small amount of laryngeal penetration and moderate amount of tracheal aspiration with puree liquids.The patient required ng and peg tube placement.

Manufacturer Narrative

Article citation: chen et al.Dysphagia following combined anterior-posterior cervical spine surgeries.J neurosurg spine 19:279¿287, 2013.Implant date: between may 2006 and august 2011.(b)(6).(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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

• 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: 4245244
• MDR Text Key: 5045712
• Report Number: 1030489-2014-04348
• 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: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2014
• Initial Date FDA Received: 11/12/2014
• 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): Required Intervention
• Patient Age: 00056 YR