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 Pain (1994); Swelling (2091); Vomiting (2144); Post Operative Wound Infection (2446); Abdominal Distention (2601)

Event Date 01/08/2016

Event Type  Injury  

Manufacturer Narrative

Multiple products were implanted -unknown rhbmp-2/acs, unknown bone graft matirx, (prod.Id/lot no./qty)- (2922245/xd29/1); (2152212/92ah/1); (2922250/yz25/1); (2922245/38ag/1) it is unknown which product caused the adverse event.We are filing this mdr for notification purpose.(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

Initial diagnosis: spinal stenosis l4-l5: left lateral recess, left foraminal, right lateral recess, right foraminal l5-s1: left lateral recess, left foraminal, right lateral recess, right foraminal mechanical instability l2-l3, l3-l4, l4-l5, l5-s1 multilevel discopathies l2-s1 it was reported that on: on (b)(6) 2015: patient presented with neurological disorder: radiculopathy.The patient also had pain with a score of 4.On (b)(6) 2016 the patient underwent anterior and posterior instrumentation at l2-s1.One cage was implanted at levels l2-l3; l3-4; l4-5 and one cage was implanted at l5-s1.On (b)(6) 2016 post-op, the patient reported an ileus.The patient was hospitalized for eight days.The event was reported as not related.The outcome of this event was resolved without sequela.Wound infection was located at the posterior lumbar, central incision l2-s1.Approximately seventeen (17) days postoperatively, the subject was reported to have a deep wound infection.The subject was admitted to the hospital (b)(6) 2016.Site reports ¿picc line in place, intra-op cx + enterobacter cloacae on levoquin, vac in place.¿ the event was reported as not related.The outcome of this event is pending.Approximately thirty days (30 days postoperatively), the subject reported a left leg dvt.The subject was hospitalized.On (b)(6) 2016: patient underwent an oblique lumbar interbody fusion and rhbmp-2, bone graft matirx was used.On (b)(6) 2016: the patient presented with fever, nausea, vomiting and abdominal distention.The patient presented with gastro-intestinal.On (b)(6) 2016: the patient presented with deep wound infection.The wound infection was located at posterior lumbar.On (b)(6) 2016, patient presented with left leg swelling and pain.Musculoskeletal examination: some tenderness to palpation on the left thigh.Patient underwent venous color doppler ultrasound, left lower extremity.Impression: non occlusive thrombus within the left common femoral vein.On (b)(6) 2016: patient underwent a treatment with diagnosis: dvt, left leg ongoing problem.

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) 2016, the patient underwent an interbody fusion + anterior instrumentation (l2-s1).Approximately three months postoperatively,the patient reported a diagnosis of right leg dvt by internal physician.The patient reported she was not hospitalized for this event.The investigator noted the event was not related.

Manufacturer Narrative

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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5440513
• MDR Text Key: 38286542
• Report Number: 1030489-2016-00491
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2016
• 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: 00067 YR
• Patient Weight: 70