MAUDE Adverse Event Report: MSD DEGGENDORF MFG MASTERGRAFT RESORBABLE CERAMIC GRANULES; FILLER, BONE VOID, CALCIUM COMPOUND

Catalog Number	7600105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following products were used in the surgery: unknown solera set screw x 1, unknown solera rod x 2, unknown solera screw x 4 and unknown capstone cage x 1.Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.The product is not returned to manufacturer for evaluation therefore we are not able to determine the definitive cause of event.However, x-ray images are sent for review.A follow up report will be sent when results are available.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis: lumbar canal stenosis.Procedure: minimally invasive transforaminal lumbar interbody fusion (tlif).It was reported that post-op, patient felt pain when pressing the lumber region around the surgery.Inflammatory response was found by blood test.The products came in contact with the patient.

• Brand Name: MASTERGRAFT RESORBABLE CERAMIC GRANULES
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• MDR Report Key: 8170963
• Report Number: 1030489-2018-01659
• Device Sequence Number: 1697172
• Product Code: MQV
• UDI-Device Identifier: 00721902168734
• UDI-Public: 00721902168734
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/17/2018

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 Catalogue Number: 7600105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/17/2018
• 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