MAUDE Adverse Event Report: MEDTRONIC EATONTOWN MAGNIFUSE BONE GRAFT; FILLER, BONE VOID, CALCIUM COMPOUND

Catalog Number	7509215
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	10/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical review: as per hcp review this likely not due to the implanted human tissue, but the allergy tests will be the final determinant.Manufacturing assessment review: it should be noted that (b)(4) (7509215) was involved in a non-conformance in which the product was reacted in a room where a table was pulled away from the wall, breaking the silicon seal.This batch was not associated with any other non-conformances.Lab results (sterility, endotoxin, and moisture analysis) passed and all environmental monitoring samples met specification for part# 7509215, serial# (b)(4).Lab results documentation was reviewed and no abnormalities were noted.Donor file & donor eligibility records- tros confirming all recovery processes for the donors associated with the products from this complaint are compliant, and there were no other reports of adverse reactions involving tissues from these donors.Doctor has reviewed the donor chart and, in his opinion, nothing in the donor record would have caused an untoward event once transplanted.As long as there are no deviations on our end, the adverse event was not caused by donor tissues as received, processed, stored and distributed by us.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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent transforaminal lumbar interbody fusion (tlif) at l1-l4 due to back and radicular pain.Po st-op, although the patient has done well from a back pain and radicular pain standpoint, she has had hives (an allergic reaction) intermittently since her implantation.Patient does have a latex allergy, but was not knowingly exposed to latex during her surgery.

• Brand Name: MAGNIFUSE BONE GRAFT
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): MEDTRONIC EATONTOWN; 201 industrial way west; eatontown NJ 07724
• MDR Report Key: 7298642
• Report Number: 2246640-2018-00004
• Device Sequence Number: 1827447
• Product Code: MQV
• UDI-Device Identifier: 00613994986559
• UDI-Public: 00613994986559
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K082615
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2018

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: 09/10/2018
• Device Catalogue Number: 7509215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/27/2018
• 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