MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC PROGENIX(R) PLUS; FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)

Catalog Number 006005

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2009

Event Type  Injury  

Event Description

It was reported that a patient underwent an anterior cervical diskectomy at c4-5, c5-6-7, anterior cervical arthrodesis at c4 to c7, anterior cervical instrumentation at c4-c7, use of allograft, use of locally harvested autograft to treat right leg numbness and heaviness.It was reported that 4.5 years post-op that the patient was diagnosed with (b)(6) allegedly from the use of the tissue allograft implanted during this acdf procedure.

Manufacturer Narrative

(b)(4).A review of the donor certificate of analysis for this device did not reveal any non-conformances to specification or deviations in procedure which might contribute to the reported event.Medical judgment: ¿(b)(6) is one of the more common acquired viral infections.The donor was fully screened before he/she was determined to be an eligible donor for human transplantation.A life style and risk analysis questionnaire was conducted with the next-of kin.Each and every donor is also tested according to the fda regulations and the aatb standards for the presence of viruses for (b)(6).Additionally, this donor had dna testing for (b)(6) and west nile virus.It was also tested for the presence of (b)(6), and a few other infectious diseases that are not required to be done.All of the testing was negative or non-reactive indicating the absence of any infectious disease at the time of death.With all these negative tests, it is medically improbable that there is any relation of the donor tissue product to be in any way related to the development of the recipient¿s (b)(6), which was only discovered four to five years after the surgery.The two events are, in all medical probability, unrelated.¿ products from multiple manufacturers were implanted during the procedure.Although it is unlikely that a medtronic device contributed to the reported event, we are filing this mdr for notification purposes.

• Brand Name: PROGENIX(R) PLUS
• Type of Device: FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 1800 pyramid place; memphis TN 38132
• 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: 3787879
• MDR Text Key: 4383792
• Report Number: 1030489-2014-02400
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081950
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2014

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 Expiration Date: 02/23/2011
• Device Catalogue Number: 006005
• Device Lot Number: 1174230039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 05/02/2014
• Supplement Dates Manufacturer Received: 04/03/2014
• Supplement Dates FDA Received: 09/14/2017
• 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): Other
• Patient Age: 00054 YR