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 Problem Discomfort (2330)

Event Date 12/01/2012

Event Type  Injury  

Event Description

It was reported in a publication that 60 patients with diagnoses of degenerative disc disease, degenerative motion segments with stenosis, and spondylolisthesis, in whom nonoperative treatments failed, were treated with endoscopic transforaminal decompression and interbody fusion by 1 surgeon in 2 centers.The outcome measures were as follows: operating time, intraoperative blood loss, hospital stay, visual analogue scale (vas) scores for back and leg pain, scores on the (b)(6) disability questionnaire, and postoperative imaging studies.A consecutive series of patients who met the treatment criteria completed vas forms and (b)(6) questionnaires preoperatively.Surgical procedures included arthroscopic decompression of the foramina and the discs; endplate preparation and implantation of allograft bone chips and bone morphogenetic protein 2 on absorbable collagen sponge into the disc space; and percutaneous implantation of pedicle screws.Sextant was used in 17 of the patients.Postoperatively, the patients again completed the vas forms and roland-morris questionnaires.Their charts were reviewed for office notes, operative notes, hospital stay, medications, and imaging studies.The latest x-ray and computed tomography scan films were reviewed and analyzed.Patients were followed up for a minimum of 6 months.All patients had improvement of motor function.8 patients (13%) complained of residual discomfort on extension of the lumbar spine.

Manufacturer Narrative

Article citation: said osman.Endoscopic transforaminal decompression, interbody fusion, and percutaneous pedicle screw implantation of the lumbar spine: a case series report.International journal of spine surgery 6 (2012) 157¿166.Mean age was 52.8 years (range, 26 ¿ 85 years).30 females, 30 males.(b)(6).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.

• 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: 4646409
• MDR Text Key: 21178366
• Report Number: 1030489-2015-00684
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2015
• Initial Date FDA Received: 03/31/2015
• 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: 00053 YR