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

Catalog Number 7510400

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

Patient Problems Pain (1994); Numbness (2415); Sleep Dysfunction (2517)

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.Multiple products 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.

Event Description

It was reported that on (b)(6) 2012, the patient underwent anterior lumbar interbody fusion surgery on the lumbar region of her spine from vertebrae l4 to s1.Reportedly," the rhbmp-2 collagen sponge was used in the surgery".Post-op patient allegedly had "increasingly severe low back hip, groin and leg pain ".Reportedly the patient "continues to experience constant left lower back and left leg pain, and numbness down his left leg.He experiences difficulty sitting, standing and walking, must constantly change positions and require occasional use of the cane to assist in ambulation.He has no stamina and has sleeping difficulty.".

Manufacturer Narrative

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

Manufacturer Narrative

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 l5-s1 degenerative disc disease and underwent the following procedures: 1) anterior lumbar antibody fusion, lumbar 5, sacral 1.2) placement of peek interbody spacer device lumbar 4, sacral 1.3) placement of anterior titanium plate and screw construct.As per op-notes,¿ subsequently a series trial sizes-were then· utilized and an appropriate sized peek interbody spacer was identified to be appropriate size.It was then packed with bmp and then tapped in positon with excellent mechanical purchase of the peek spacer.Subsequently an awl was utilized and an anterior titanium plate screw construct was fixed to the anterior aspect of the spine with 30 mm screws.¿ 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: 6013399
• MDR Text Key: 56919461
• Report Number: 1030489-2016-02816
• 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: 12/28/2017

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: 04/01/2015
• Device Catalogue Number: 7510400
• Device Lot Number: M111110AAS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/10/2016
• Supplement Dates Manufacturer Received: 09/19/2016; 12/18/2017
• Supplement Dates FDA Received: 09/26/2017; 12/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2012
• 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