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 Problem Wound Dehiscence (1154)

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.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.

Event Description

It was reported that on: (b)(6) 2007: patient presented with following pre-op diagnoses: degenerative disc disease l3-4; degenerative spondylolisthesis with severe stenosis l4-5.For which, patient underwent following procedures: posterior spinal fusion l3 to l5; transforaminal lumbar interbody fusion l4-5; wide decompressive laminotomies with foraminotomies l4-5; titanium segmental implants l3 to l5; peak implant placement l4-5; bmp plus local bone grafting.Per op notes, surgeon placed a 9x30 mm implant peek, filled it with bmp sponges and put it on the applicator and slid it form left to right and anteriorly.Then further bmp and local bone graft were placed posterior to the cage and imploded.Ap and lateral x-rays were taken confirming good restoration of disc height, reduction of the spondylolisthesis and good alignment as well as good implant placement at l4-5.Patient tolerated the procedure well without any intraoperative complications.On (b)(6) 2007: patient presented with following pre-op diagnosis: spinal wound dehiscence.For which, patient underwent following procedures: irrigation and debridement, primary closure.Patient tolerated the procedure well without any intraoperative complications.

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: 5801814
• MDR Text Key: 49746468
• Report Number: 1030489-2016-02087
• 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: 06/21/2016

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
• Device Catalogue Number: 7510800
• Device Lot Number: M110801AAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 07/18/2016
• Supplement Dates Manufacturer Received: 06/21/2016
• Supplement Dates FDA Received: 09/23/2017
• 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): Other
• Patient Age: 59 YR
• Patient Weight: 58