MAUDE Adverse Event Report: OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) GRAFTON DBM; FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)

Model Number NOT REPORTED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

A patient reported that she received allograft bone void filler during her cervical spine fusion procedure in 2007 and states that she is currently having ¿difficulty swallowing, nerve pain (c6-c7 nerve root) and chronic symptoms with decreased mobility.¿ the patient did not provide any specific product or lot information.The patient denied having had any post-operative infection or revision procedures.No additional information was provided.

Manufacturer Narrative

No medwatch form was received from the user facility, therefore, this medwatch was completed using the information provided by the initial reporter.Any missing or incomplete information is the result of the information not having been provided by the initial reporter.(b)(4).

• Brand Name: GRAFTON DBM
• Type of Device: FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)
• Manufacturer (Section D): OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC); 201 industrial way west; eatontown NJ 07724
• Manufacturer (Section G): OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC); 201 industrial way west; eatontown NJ 07724
• Manufacturer Contact: edward wheeler ; 201 industrial way west; eatontown, NJ 07724 ; 7325422800
• MDR Report Key: 3828204
• MDR Text Key: 4500209
• Report Number: 2246640-2014-00004
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051195
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/23/2014

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
• Device Model Number: NOT REPORTED
• Device Catalogue Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2014
• Initial Date FDA Received: 05/22/2014
• 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): Disability