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

Catalog Number 7510200

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

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

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.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on (b)(6) 2012, patient underwent spine fusion surgery in the lumbar region of spine from vertebrae l4-5.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.Allegedly, "the patient continues to suffer from chronic pain.".

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

Additional info: products from multiple manufacturers were implanted during the procedure.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6) 2012: the patient was pre-operatively diagnosed with l4-5 disc protrusion with annular tear and underwent the following procedures: l4-5 anterior lumbar interbody fusion via direct lateral approach.Placement of fusion cage at l4-5.Placement of bone morphogenic protein (rhbmp-2).As per op-notes, ¿after placement of the retractor, the annulotomy, diskectomy, release of the opposite anulus, serial trial, and gentle distraction of the disk space was performed until a 22 mm anterior-posterior length 10 mm height lordosed.A 45 mm in length co ronet cage was placed, prefilled with a small kit of bone morphogenic protein saturated to collagen tricalcium phosphate sponge (former graft) good distraction at the disk spaces and neural foramina, and good position was achieved with good stability¿.The patient tolerated the procedure well without any intraoperative complications.

• 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: 6208024
• MDR Text Key: 63359858
• Report Number: 1030489-2016-03588
• 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: 10/26/2017

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: 03/01/2015
• Device Catalogue Number: 7510200
• Device Lot Number: M111110AAM
• 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; 10/02/2017
• Supplement Dates FDA Received: 09/28/2017; 10/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2012
• 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