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

Catalog Number 7510100

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

Patient Problem Urinary Retention (2119)

Event Type  Injury  

Manufacturer Narrative

Implanted date : 2013.(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

Implant date: 2013.It was reported that the patient presented with radiculopathy, extremity pain, motor weakness and diminished reflex.The patient was diagnosed with spondylolisthesis, degenerative disc disease, stenosis and back pain.The patient underwent an open posterior lumbar surgery consisting of fusion at l4-l5, laminectomy (with greater than 50% facetectomy) at l4-l5, and discectomy at l4-l5.Autologous local bone, rhbmp-2/acs and static instrumentation- pedicle screw/rod at l4-l5, and cage at l4-l5 were used in the surgery.X-ray verification of levels was done.The patient was placed in neurologic monitoring.This procedure was a revision of a prior spine surgery.The patient was discharged home.The patient's 30-day nrs was 1.The patient's 30-day odi was 12.The patient presented for post-discharge follow ups.The patient developed urinary retention post-op.

• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4999119
• MDR Text Key: 22820779
• Report Number: 1030489-2015-01986
• 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: study
• Reporter Occupation: Other
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2015
• 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: 00071 YR
• Patient Weight: 85