MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK INDUCTOS

Catalog Number 751090001

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 09/17/2013

Event Type  Injury  

Event Description

It was reported in a publication that a retrospective chart review of patients with iatrogenic spondylolisthesis including pre and p ost-operative oswestry disability index (odi) and visual analogue scale (vas) scores was performed.The fusion rate was investigated after 6 months.Six consecutive patients treated between 2008 and 2011 (4 female, 2 male, mean age 61 ± 7.1 years) were identified.The initially performed surgeries included decompression with or without discectomy; posterior instrumented and non-instrumented fusion.The olisthetic level was in all cases at the decompressed level.All patients were revised with a synthes syncage stand-alone anterior interbody fusion devices at the olisthetic level filled with rhbmp-2/acs.Fusion was confirmed in five patients through obvious osseous bridging of the alif implant on plain x-ray or ct.Patient number 5, a (b)(6) female, history of l3-4, l4-5 decompression 96 months prior, presented with grade 1 l4 spondylolistheses is and underwent l3-4, l4-5 alif.There were no intraoperative complications.The patient showed a cage subsidence into the vertebral body of l3 after 6 months due to severe osteoporosis.No further follow-up was therefore possible.A revision posterior instrumented fusion and cement augmentation was later performed.

Manufacturer Narrative

Article citation: könig et al.Early results of stand-alone anterior lumbar interbody fusion in iatrogenic spondylolisthesis patients.Eur spine j (2013) 22:2876¿2883.This part is not approved for use in the united states; however a like device catalog # 7510800, product code nek was cleared in the united states.Implanted: between 2008 and 2011.(b)(4).This part is not approved for use in the united states; however, a like device catalog # 7510800, pma # p000058 was cleared in the united states.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.

• Brand Name: INDUCTOS
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN
• 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: 4743768
• MDR Text Key: 5706034
• Report Number: 1030489-2015-00893
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2015

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: 751090001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 05/01/2015
• 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 Age: 00068 YR