MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC MASTERGRAFT; FILLER, BONE VOID, CALCIUM COMPOUND

Catalog Number	7600701
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction (2414)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Allergic reaction.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 whether this product caused or contributed to the reported event, we are filling this mdr for notification purpose.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 at 2 levels.The product was placed in a cage in disc space.On an unknown date, post-op, patient suffered with unspecific allergic reaction.There is, however, no proof if the patient conditions were related to the implanted products.It was not clear from where the allergic symptoms were coming.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Procedure performed on (b)(6) 19: l3-l5 'lws' fixation with pedicle screw (from neo medical) and two cages.There is no plan to perform revision surgery, and to remove the implanted products.The doctor has only requested material testing of the alleged product.

• Brand Name: MASTERGRAFT
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 9802770
• Report Number: 1030489-2020-00276
• Device Sequence Number: 10909212
• Product Code: MQV
• UDI-Device Identifier: 00643169486416
• UDI-Public: 00643169486416
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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: 08/31/2022
• Device Catalogue Number: 7600701
• Device Lot Number: 7001162
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 04/24/2020
• 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