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

Catalog Number	7510200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient underwent anterior lumbar inter-body fusion at l5-s1 in which rhbmp-2/acs and cage was used along with her bone from her iliac crest.Post-operatively, patient is suffering from severe pain starting in her lower back, buttocks and legs, more on the left than on the right.Patient has nerve root exposure at s1.Patient was discharged from the hospital prior to having a bowel movement and so was impacted.Patient had to strain after getting home to have a bm, which patient feels caused the nerve root to be exposed thus causing this issue with the pain.Allegedly, patient is unable to work or do every day movements.Patient only finds relief by taking pain pills and muscle relaxers.The doctor says that scar tissue could be the cause of the problem and disagrees with patient's theory.As a result of this event, patient underwent emg which showed some s1 nerve root irritation; however, mri with contract did not show anything.

• 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
• MDR Report Key: 7514148
• Report Number: 1030489-2018-00677
• Device Sequence Number: 11188494
• Product Code: NEK
• UDI-Device Identifier: 00681490843782
• UDI-Public: 00681490843782
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/15/2018

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: 04/01/2018
• Device Catalogue Number: 7510200
• Device Lot Number: M111611AA2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 05/15/2018
• 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