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 Problems Ossification (1428); Scarring (2061); Discomfort (2330); Injury (2348)

Event Type  Injury  

Event Description

It was reported that the patient underwent an unspecified surgery where rhbmp-2/acs was implanted at l2-3, l3-4, and l4-5.Post-operatively, the patient developed unspecified injuries.No further information was provided.

Manufacturer Narrative

(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.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.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient underwent surgical procedure , during which the patient was implanted with longitude posterior spinal instrumentation including 8 pedicle screws(6.5 mm in diameter x 45 mm in length) at levels l2, l3, l4 and l5; 2 rods( 5.5mm in diameter x 100mm in length) and 8 set screws.The patient was also implanted with 2 peek cages( one measuring 10mm in height x 50mm in lenght x 22mm in width and the other one 14mm in height x 50mm in length x 22mm in width) and an rhbmp-2/acs medium kit.Post-op, the patient complained of back pain and discomfort, allegedly due to a defective implant inserted into his spine during surgery.An mri revealed the defective implant and a second surgery was scheduled , in order to remove and replace the said implants.The june surgery was second spinal surgery, during which it was discovered, through mri that the existing implant was broken in half while inside of the patient's body.The defective implant, reportedly, resulted in significant bone growth leading to a total of five (5) corre ctive surgeries.The patient complained of extensive pain, mental anguish, difficulty in sleeping, worrying and affected personality due to this event.The patient has undergone multiple therapy for recovery from this event.The patient has been prohibited from daily activities such as walking, driving, lifting, and swimming.The patient reportedly had a long and very noticeable scar on his back.

Event Description

It was reported that on (b)(6) 2012 the patient underwent following procedures, circumferential fusion, l4-5.Extracavitary right retroperitoneal transpsoas approach, l2-3 and l4-5.Anterior arthrodesis by direct lateral interbody (lif) technique, l2-3.Anterior arthrodesis by direct lateral interbody (lif) technique, l4-5.Placement of peek interbody cage via direct lateral interbody technique l2-3.Placement of peek interbody cage via direct lateral interbody (lif) technique, l4-5.Exploration of spinal fusion, l3-4.Posterolateral arthrodesis, l4-5.Osteotomy, l4-5.Posterior segmental spinal instrumentation, l2-3, l3-4 and l4-5.Placement of bone allograft matrix, l2-3 and l4-5.Placement of rhbmp-2 l2-3 and l4-5.Somatosensory evoked potential, motor evoked potential (mep) and electromyographic (emg) monitoring with screw stimulation.Surgeon driven emg monitoring.Fluoroscopic guidance and interpretation, lumbar spine.Preoperative diagnosis, lumbar spondylosis, history of chronic low back pain, flat back deformity, status post anterior lumbar interbody fusion, l3-4.Status post posterior spinal fusion and instrumentation, l3-4.Status post removal of hardware, l3-4.As per op notes: ¿the corresponding peek cage measuring 14mm in heightx50mm in length x22mm in width with 12 degrees lordosis was passed to the side table.Medium kit rhbmp-2 was prepared approximately 30 mins prior to implantation by soaking the corresponding sponges with bone morphogenic protein.Two such sponges were rolled over the bag of cancellous bone autograft matrix, with the corresponding 5cm kit.Such roll of matrix and rhbmp-2 was loaded into the corresponding peek cage, which was thereafter deposited into the l4-5 interbody space under direct visualization.¿¿ ¿the remaining rhbmp-2 sponges from the corresponding medium kit were rolled over the second bag from the 5cm kit of bone allograft matrix, rhbmp-2 with bone matrix were loaded into the corresponding peek cage, which was then deposited into the l2-3 interbody space under visualization.Proper positioning of such interbody device within the interbody space was noted, as well restoration of interbody height with associated of overall interbody height.¿.

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.

• 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: 4275787
• MDR Text Key: 5224378
• Report Number: 1030489-2014-04567
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2017
• 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): Other; Required Intervention
• Patient Age: 51 YR