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

Catalog Number	7600105
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that patient underwent transforaminal lumbar interbody fusion at levels l4-5.Post op,on (b)(6) 2017, post op, radiology report pointed out an artificial bone (equivalent to bone) is flowing in the spinal canal (until l2-3).The device was used in a cage and the intervertebral disc with autologous bone by means of plf because the amount of autologous bone was not enough.There is a possibility that the artificial bone used for the intervertebral disc is melted.The patient complained of pain in the femur in the 4th day after the surgery.Neurological symptom has not occurred.
Additional Manufacturer Narrative
Post op ct images show a hyper dense object in the epidural space at c3 posterior.It is not clear what this is.Possibilities include bone wax, bone graft of other radiopaque material which was placed in the epidural space at the time of the surgery.Not aware of any circumstances under which allograft can melt and migrate at physiologic temperatures.If information is provided in the future, a supplemental report will be issued.

• 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: 6903279
• Report Number: 1030489-2017-02138
• Device Sequence Number: 1354164
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2022
• Device Catalogue Number: 7600105
• Device Lot Number: 212882082
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 10/10/2017
• 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