MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number	7510400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported in a post-market study that the patient was pre-operatively diagnosed with stenosis with instability and underwent posterior lumbar fusion (plf) surgery at l2-s1 levels.Post-operatively, the patient complained of low back pain.The adverse event (ae) was concluded as being non-serious.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient underwent for follow up visit on (b)(6) 2019.Date of diagnosis as related patient cancer: (b)(6) 2019 date of pathology report: (b)(6) 2019 cancer results: cells positive for ck7, focally positive for cdx2 and pax 8 with weak positivity for gata-3 and are negative for ck20, er, mammaglobin, gcdfp-15, ttf-1, and napsin-a.Location / type of cancer: pancreas-pancreatic cancer medications taken within 30 days of cancer diagnosis: yes.

• Brand Name: INFUSE BONE GRAFT
• Common Device Name: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7863237
• Report Number: 1030489-2018-01225
• Device Sequence Number: 16628993
• Product Code: NEK
• UDI-Device Identifier: 00681490843805
• UDI-Public: 00681490843805
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P000058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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: 09/30/2018
• Device Catalogue Number: 7510400
• Device Lot Number: M111613AAA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 11/19/2019
• 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 Weight: 98