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 Pain (1994); Neck Pain (2433); 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 in (b)(6) 2013, patient underwent posterior fusion at l5-s1, with instrumentation and placement of augmentation with rhbmp-2/acs at each level, where in the surgeon implanted an rhbmp-2 bone graft to facilitate spinal fusion, via spinal fusion surgery, along with pedicle screws and cages.Near (b)(6) 2014, eight months post-surgery, patient reported a "jolt to the spine".Shortly thereafter, patient began to experience pain in back, neck, shoulders, and arms.In (b)(6) 2014, patient visited his physician and complained of pain in his thoracic area, neck, back, and down his legs and right arm.Routine x-rays revealed a cracked s1 right pedicle screw in his thoracic spine at the location of the 2013 laminectomy.Several weeks later, another set of x-rays were taken and the x-rays showed a completely broken and separated pedicle screw.Between (b)(6) 2014 and (b)(6) 2015, patient continued working, but the pain continued to increase.In (b)(6) 2015, the pain was so severe that he was taken off of work and remains unable to work.In (b)(6) 2015, patient underwent revision surgery (hardware removal, anterior release, posterior fusion) to replace the cages and pedicle screws at l5-s1 installed in 2013.

• 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: 5948659
• MDR Text Key: 54626652
• Report Number: 1030489-2016-02531
• 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
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• 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
• Date Manufacturer Received: 08/22/2016
• 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