MAUDE Adverse Event Report: MEDTRONIC EATONTOWN GRAFTON DBM; BONE GRAFTING MATERIAL, HUMAN SOURCE

Catalog Number	T42308INT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Herpes (1898)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical review: per hcp review, "such a transmission from reported tissues, as processed and handled by manufacturer is impossible." manufacturing assessment review: the non-conformance database was reviewed and there were no non-conformances found for serial# (b)(4), part# t42308int related t o the complaint.Also, manufacturing records were reviewed (reacting router, core packaging router)for the grafton matrix plug batch (b)(4), product code t42308-ifp and no deviations were found.The device was not 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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient underwent dental surgery in which the bone graft was used.It was reported that post-operatively, the patient complained of having herpes 1 and 2 virus.The surgeon is unsure if the cause of the disease is the graft.
Event or Problem Description
Reportedly, patient was tested (b)(6).No revision surgery has been planned at this time.
Additional Manufacturer Narrative
Final hcp review: the files have been reviewed and approved.Per hcp's conclusion, any adverse reportable event could not have been caused by tissues from this donor as recovered and processed by the agencies listed in the paperwork.Further, provided all of our processing paperwork is in order with no deviations, any reported adverse event would not have been caused by tissues from this donor as received, processed, stored and distributed by manufacturer.Donor review results: no other complaints or reports of infection involving organs/tissues recovered from this donor observed.Recovery of the subject donor tissue was performed using a method appropriate to controll contamination.There were no deviations from established procedures that may have increased the risk of contamination/cross contamination.All supplies and reagents used during the recovery were in compliance with 21 cfr 1271.210.The recovery was performed within the established time and temperature limits for recovery.If information is provided in the future, a supplemental report will be issued.

• Brand Name: GRAFTON DBM
• Common Device Name: BONE GRAFTING MATERIAL, HUMAN SOURCE
• Manufacturer (Section D): MEDTRONIC EATONTOWN; 201 industrial way west; eatontown NJ 07724
• MDR Report Key: 7240885
• Report Number: 2246640-2018-00001
• Device Sequence Number: 11018588
• Product Code: NUN
• UDI-Device Identifier: 00643169134539
• UDI-Public: 00643169134539
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K051188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2019
• Device Catalogue Number: T42308INT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 03/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR