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 Problems Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 that on: (b)(6) 2005, the patient presented with pre-op diagnosis of degenerative disk disease with back and leg pain.The patient underwent following operative procedures: l5-s1 plif through tubes using peek cages with rhbmp-2 and spinal instrumentation.Per op-notes, ".The surgeon used the medium circular cutter , scraper and chisel to prepare disk space first on the left side and then the right side for two 10x20 peek cages that were stuffed with rhbmp-2.Then prepared the l5 pedicles for 6.5 x 40 mm screws and the s1 pedicles with 7.5 x35 mm screws.Ultimately used instrument arc to two 40 mm rods in from an inferior approach."on (b)(6) 2006, the patient presented with pre-op diagnosis of status post l5 pathologic fracture after a posterior lumbar interbody fusion , pseudoarthrosis with instability , post reconstruction, intractable back pain and bilateral leg pain, right greater than left , and residual cauda equine syndrome.The patient underwent l3,l4, and iliac crest pedicle screw and rod fixation with a lateral posterior fusion using rhbmp-2 and bonegraft.

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: 5952049
• MDR Text Key: 54749405
• Report Number: 1030489-2016-02551
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 08/29/2016

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?: No
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/15/2016
• Supplement Dates Manufacturer Received: 08/29/2016
• 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): Required Intervention