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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Literature citation: bingyi tan, haiyan wang, jun dong, zenong yuan, dachuan wang, feng wang." comparison of rhbmp-2 versus autogenous iliac crest bone graft for 2 level anterior cervical discectomy and fusion for cervical spondylotic myelopathy" gender: 42 males and 31 females.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.

Event Description

It was reported in an abstract, between (b)(6) 2007 and (b)(6) 2011, medical records of a total of 83 consecutive patients, with mean age 64 yrs, diagnosed with csm and who underwent a 2-level (2 or more levels) acdf with iliac crest bone graft plus rhbmp-2/acs (0.9 mg of rhbmp-2 per level) along with plate fixation in our hospital were retrospectively reviewed.All patients were placed in the supine position on the operating room table, and underwent acdf with autogenously icbg which mainly consisted of complete discectomy and burring down of the uncinated processes.Rhbmp-2 was reconstituted according to the manufacturer's instructions and combined with local autograft.The same screw rod implant system was used in all subjects.In the rhbmp-2 group, 1 patient reported with iliac crest site deep infection.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5959207
• MDR Text Key: 54991895
• Report Number: 1030489-2016-02585
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2016

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2016
• Initial Date FDA Received: 09/19/2016
• Supplement Dates Manufacturer Received: 08/23/2016
• Supplement Dates FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR