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

Catalog Number 7510600

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

Patient Problems Pain (1994); Sore Throat (2396)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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

Levels: l4-s1 it was reported that on (b)(6) 2006, the patient underwent spinal fusion surgery on the lumbar region at l4-s1, where only rhbmp-2 and collagen sponge were used.The rhbmp-2 collagen sponge was placed outside the cage.Severe pain and symptoms compelled patient to undergo a revision surgery.

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.

Event Description

It was reported that on: (b)(6) 2006: patient presented with preop diagnosis as: degenerative disk disease l4-5 and l5-s1.For which, patient underwent left iliac bone graft harvest with reconstruction.Posterolateral fusion l4-l5, l5-s1.Internal fixation with l screw system.Rhbmp-2 and autogenous bone graft was used for the fusion.Per op notes, total capsulectomies were performed at l4-5 and l5-s1.The facet joints were burred and filled with rhbmp-2 and autograft.Autogenous bone graft and rhbmp-2 was placed over the transverse process of 4-5 and the sacral ala which were decorticated.Rhbmp-2 was placed over there as well as autogenous bone graft.Further bone graft was placed over the pars articularis and underneath the rod.Patient tolerated the procedure well with no complications reported.

Manufacturer Narrative

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

Event Description

It was reported that on an unknown date,the patient underwent exposure of l5,s1 vertebral interspace.Exposure of l4-l5 intervertebral body space.

• 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: 5150801
• MDR Text Key: 28296998
• Report Number: 1030489-2015-02682
• 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: Followup,Followup
• Report Date: 12/01/2017

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 Catalogue Number: 7510600
• Device Lot Number: M116006AAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided; 11/06/2017
• Supplement Dates FDA Received: 04/28/2016; 12/01/2017
• 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): Required Intervention
• Patient Weight: 97