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 Problems Fitting Problem (2183); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2003: the patient presented with following pre-op diagnosis: pseudarthrosis lumbar spine, l4-l5, l5-s1.Lumbar degenerative instability, l3-l4.Failed posterior spinal instrumentation, pedicle screws in l4 and s1.Status posts multiple low back operations, including laminectomy and instrumented spinal fusion l4 to the sacrum, with non-segmental instrumentation (steffee plate and screws in l4 and 51).The patient underwent the following procedures: arthrodesis lumbar spine via retroperitoneal exposure, anterior body fusion l5-s1.Additional revel, arthrodesis lumbar spine, anterior lumbar interbody fusion l4-l5.Additional level, arthrodesis lumbar spine, anterior lumbar interbody fusion l3-l4.Insertion of a prosthetic device in the interbody space, peek cage l5-s1.Additional level, insertion of a prosthetic device in the interbody space, peek interbody cage at l4-l5.Additional level, insertion of a prosthetic device in the interbody space, peek cage in the interbody space at l3-l4.Insertion of bone morphogenic protein(bmp) in the interbody cages at l3-l4, l4- l5, and l5-s1.As per operative notes,¿ a 16-mm anterior height cage with an 8- degree lordotic angle was packed with bone morphogenic protein(bmp) on the collagen sponge.The cage was then inserted into the disc space at l3-4.Again the cages were placed under c-arm guidance, with good bony contact.The cages were tight in their disc spaces.Gelfoam was placed over the annulotomy sites.¿ no intra-operative complications were reported.

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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7677011
• MDR Text Key: 113636864
• Report Number: 1030489-2018-00980
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843829
• UDI-Public: 00681490843829
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510800
• Device Lot Number: M0111001B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• 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