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

Catalog Number 7510800

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

Patient Problems Neuropathy (1983); 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) 2013, patient was admitted to the facility, where the surgeon performed spine fusion surgery involving rhbmp2 on the lumbar region of his spine from vertebrae l3 to s1.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the transverse process facet complex).Post-op, "patient had progressively worsening lower back pain and radiculopathy in his lower extremities.Due to severe pain patient underwent a revision surgery on (b)(6) 2013.".

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

It was reported that on: (b)(6) 2013: the patient was pre-operatively diagnosed with: degenerative disc disease.Hnp (herniated nucleus pulposus) with instability of l3-l4 and l5-s1.Lumbar radiculopathy.The patient underwent the following procedures: anterior approach, anterior retroperitoneal exposure at l3-l4 and l5-s1.Anterior lumbar discectomy at l4 and l5-s1.Anterior lumbar interbody fusion with rhbmp-2, autograft matrix at l3-l4 and l5-s1.Imitation peek interbody cage fixation, l3-4, l5 and s1.Primary anterior plate screw fixation, l5-s1.Anterior plate and screw fixation, l3-l4.As per operative-notes, ¿distraction was done at endplate preparation with custom distractors placed.Appropriate-size peek interbody cage was brought with rhbmp-2, prepared with manufacturer specification prior to the case with distraction and compression into the disc space.Next, appropriate size plate for l3-l4, anterior plate at l5-s1 was selected and joint tapping was placed at both size for screw fixation and locking mechanism was applied.¿ the patient underwent the following post-procedure(part2): posterior bilateral partial facetectomy and foraminotomies, l5-s1.Posterolateral transverse process facet fusion with rh-bmp2, autograft matrix, l5-s1.Cortical screw fixation, l5-s1.Ssep pedicle screw stimulation technique.As per operative-notes, ¿a 4 cm incision was made over l5-s1 carried down to the subcutaneous fat to the thoraco-dorsal fascia with sub periosteal dissection along the lateral lamina and lateral parts and medial transverse process.Drilling tap in preparation of the sites for pedicle screws was done with measuring.Next, limited laminotomy and decompression was done with reflecting the ligamentum flavum and checking for any residual compression.The bone that was re-harvested and decortication of lateral part mid transverse process facet complex was done at l5-s1.The rhbmp-2/acs was placed in the facet complex for bony fusion from l5-s1.¿ no patient complications were reported.

• 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: 6207985
• MDR Text Key: 63358800
• Report Number: 1030489-2016-03552
• 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,Followup
• Report Date: 09/18/2017

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
• Device Expiration Date: 07/01/2015
• Device Catalogue Number: 7510800
• Device Lot Number: M111111AAP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: 12/05/2016; 09/18/2017
• Supplement Dates FDA Received: 09/27/2017; 10/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2012
• 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