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 Neuropathy (1983); Stenosis (2263); No Code Available (3191)

Event Type  Injury  

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.

Event Description

It was reported per patient¿s medical records that on (b)(6) 2004, the patient presented with the following preoperative diagnoses: status post laminectomy and posterior lumbar interbody fusion attempt with pedicle screw-rod instrumentation l4-5, l5-s1.Probable pseudoarthrosis l4-5, l5-s1.Indications for the procedure: the patient had intractable back pain with radiation to both lower extremities.She underwent posterior lumbar interbody fusion with cages on (b)(6) 2003.Pedicle screw-rod instrumentation was carried out at l4-5 and s1.Posterolateral bone grafting was not performed in the procedure.The patient had become more disabled in regards to routine activities of daily living.Preoperative examinations revealed restriction of lumbar spine motion.X-ray of the lumbar spine demonstrated lucency about several of the screws.Motion was demonstrated on dynamic x-rays of the lumbar spine in flexion and extension.Due to the intractability and severity of her symptoms and the known pseudoarthrosis present, surgical intervention was recommended.Hence, the patient underwent the following procedures: removal of segmental instrumentation at l4-5 and s1.Exploration of pseudoarthrosis l4-5, l5-s1.Revision of pseudoarthrosis via posterolateral arthrodesis at l4-5 and l5-s1.Isola stainless steel pedicle screw-rod segment instrumentation at l4-5, l5-s1.Bilateral autologous iliac crest bone graft.Intraoperative spinal cord monitoring.As per the op notes, ¿¿removed all six of the screws of the instrumentation.The right s1 screw was fractured, consequence of the effects of pseudoarthrosis¿ due to obliquity of the superior endplate of l4¿ the patient¿s autologous bone graft was packed into the intertransverse spaces.This was supplemented with rhbmp-2, bone morphogenic protein.The medium size was utilized.This was also supplemented with bone graft¿ x-rays demonstrated excellent position of the instrumentation¿¿ no patient complications were reported.

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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6563235
• MDR Text Key: 75035839
• Report Number: 1030489-2017-01199
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843805
• UDI-Public: 00681490843805
• 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
• Report Date: 04/17/2017

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: 7510400
• Device Lot Number: M111006AB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2017
• Initial Date FDA Received: 05/12/2017
• Supplement Dates Manufacturer Received: 04/17/2017
• Supplement Dates FDA Received: 10/03/2017
• 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