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

Model Number 7510600

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

It was reported that the patient developed unspecified injuries following the use of rhbmp-2/acs in an unspecified spinal fusion surgery.No additional information was reported.

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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that (b)(6) 2010: patient underwent posterior fusion surgery using rhbmp2/acs, allograft paste and plif spacers.On (b)(6) 2013: patient underwent mri lumbar spine without contrast due to orthopedic hardware, pain, radiculopathy.Impression: native disc parenchyma noted at t12 --- l1.2 mm disc bulge; probable native disc without spacer material at l2 ---3.Central to right lateral disc protrusion measuring 2.5 mm; at the l3 --- 4 level there is a 3 mm impression upon the ventral subarachnoid space.This could represent disc bulge versus scar tissue; at the l4 - 5 level, there is a 4 mm impression upon the ventral subarachnoid space.This could represent disc bulging versus scar tissue.Fluid signal along the posterior periphery of this disc suggestive of annular tear; there is rounded fluid signal intensity structure along the posterior aspect of the thecal sac at the l4 - 5 level.This is felt to represent a seroma; at the l5 - s1 level, there is a 3 mm impression upon the ventral subarachnoid space.This likely represents a disc bulge.Can not rule out annular tear along the right lateral periphery of the interspace.

• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4021560
• MDR Text Key: 17630412
• Report Number: 1030489-2014-03492
• 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: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2012
• Device Model Number: 7510600
• Device Catalogue Number: 7510600
• Device Lot Number: M110812AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2012
• 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