MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNKNOWN; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number MSB_UNK_CAGE

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

Patient Problem Nerve Damage (1979)

Event Date 04/25/2023

Event Type  Injury  

Event Description

Vishwajeet singh., marcelo oppermann., nathan evaniew., alex soroceanu., fred nicholls., w.Bradley jacobs., ken thomas., ganesh swamy.¿l5-s1 pseudoarthrosis rate with alif versus tlif in adult spinal deformity surgeries: a retrospective analysis of 100 patients¿.World neurosurgery.Volume 175, july 2023, pages e1265-e1276.Doi.Org/10.1016/j.Wneu.2023.04.113.Objective: lumbosacral pseudoarthrosis is a common complication following adult spine deformity (asd) surgery.This study assessed the reoperation rate for l5-s1 pseudoarthrosis in the asd population.Compared with transforaminal lumbar interbody fusions (tlifs), we hypothesized that anterior lumbar interbody fusion (alif) would result in lower rates of l5-s1 pseudarthrosis.Methods: this is a single center study with patient data retrieved from a prospective asd database.The patients had a long-segment fusion, alif or tlif at the l5-s1 level with a 2-year follow-up and were divided into 2 groups (tlif and alif).The study¿s primary outcome was to assess the difference in the reoperation rate for clinical pseudoarthrosis between the tlif and the alif groups.The secondary outcomes measured the radiological pseudoarthrosis rate and identified risks for l5-s1 pseudoarthrosis development.Conclusions: no difference in reoperation risk for l5- s1 pseudarthrosis was observed based on the method of if.Rhbmp-2 was noted as a significant predictor.Reportable event: a total of 184 patients were available in the institutional asd database, of which 100 patients with a minimum 2-year follow-up met the inclusion criteria.Patients with incomplete imaging studies, shorter follow-ups, and no sp fixation were excluded.Patients were divided into 2 groups (tlif-group:49; alifgroup: 51) based on the l5-s1 if: tlif-group and alif-group method.The baseline characteristics of both groups were similar.The mean age for patients in the tlif group was 62.9 years and 64.4 years for the alif group.There were 77.5% and 70.6% females in the tlif and alif groups, respectively.A single vascular complication was encountered in the alif group; a venous injury was noticed after retractor removal, and this patient required vascular repair.

Manufacturer Narrative

D1,d4: product identifiers are unknown.G4: since the product identifiers are not available, 510k number is unknown.Vishwajeet singh., marcelo oppermann., nathan evaniew., alex soroceanu., fred nicholls., w.Bradley jacobs., ken thomas., ganesh swamy.¿l5-s1 pseudoarthrosis rate with alif versus tlif in adult spinal deformity surgeries: a retrospective analysis of 100 patients¿.World neurosurgery.Volume 175, july 2023, pages e1265-e1276.Doi.Org/10.1016/j.Wneu.2023.04.113.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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: UNKNOWN
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 17267664
• MDR Text Key: 318550059
• Report Number: 1030489-2023-00490
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_CAGE
• Device Catalogue Number: MSB_UNK_CAGE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2023
• 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: 64 YR
• Patient Sex: Female