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

Model Number MSB_UNK_CLYD_IMP

Device Problem Unintended Movement (3026)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/05/2022

Event Type  malfunction  

Event Description

Zhao xie, zeng long tianhang xiandi wang, zhiqiang yang, xingxiao pu, yufei lu and jiancheng: clinical and radiological evaluation of cage subsidence following oblique lumbar interbody fusion combined with anterolateral fixation.Summary: cage subsidence (cs) was previously reported as one of the most common complications following oblique lumbar interbody fusion (olif).We aimed to assess the impacts of cs on surgical results following olif combined with anterolateral fixation, and determine its radiological characteristics as well as related risk factors.Two hundred and forty-two patients (age 77-55) who underwent olif at l4-5 and with a minimum 12 months follow-up were reviewed.Patients were divided into three groups according to the extent of disk height (dh) decrease during follow-up: no cs (dh decrease = 2 mm), mild cs (2 mm <(><<)> dh decrease = 4 mm) and severe cs (dh decrease > 4 mm).The clinical and radiological results were compared between groups to evaluate radiological features, clinical effects and risk factors of cs.Oblique lumbar interbody fusion (olif) is an effective treatment for patients with degenerative lumbar disc disease.Indirect decompression of neural elements can be achieved by distracting the reduced intervertebral space with an enlarged interbody cage, thus alleviating neurogenic intermittent claudication maintaining the restored intervertebral space is one of the fundamental requirements following.However, as a complication resulting in loss of the intervertebral space.Cage subsidence (cs) has been reported as common event following olif, with an incidence rate between 10.0%-40.0% [4, 5].Currently, variability exists in the impact of cs on surgical outcomes after traditional lumbar interbody fusion (lif) surgery, with reports of non-adverse events in some studies [6, 7], while other studies report adverse events that cause pain and even failure of surgery [8, 9].To our knowledge, no early studies have thoroughly addressed whether cs affects surgical outcomes following olif.We launched this study to determine the impact of cs on clinical and radiological results following olif combined with anterolateral fixation, and to further study its occurrence characteristics and related risk factors, so as to provide recommendations for preventing cs.After general anaesthesia intubation, a right lateral decubitus position was taken.A 6-cm skin incision was made in the left lateral abdominal region parallel to the iliac crest.The external oblique, internal oblique, and transverse abdominal muscles were dissected along their fibres, and then a 22-mm-diameter tubular retractor was attached after reaching the index disc.Subsequently, discectomy and endplate preparing were performed.The cartilaginous endplate was removed using reamer and curette until minor bleeding was identified.Then, an appropriate polyetheretherketone cage (clydesdale spinal system, medtronic sofamor danek usa, inc.) (height: 8¿14 mm, length: 45¿55 mm, width:18 mm, lordotic angle: 6°), whose size was determined by sequential trail implant testing, was filled with the recombined human bone morphogenetic protein-2 (cpc rhbmp-2, rebone, shanghai, p.R.C.) and inserted.Next, two screws (length: 40 mm-55 mm, diameter: 6.5 mm) (medtronic sofamor danek usa, inc) were fixed at the lateral side of the vertebrae close to endplate and locked using a single rod (length: 38 mm-42 mm, diameter: 5.5 mm).Finally, abdominal muscle and incised skin were closed.Reported events: 1.Total of 79 patients were identified with cage subsidence in which 61 patients had only cage subsidence with mild and severe cs group.2.18 patients had endplate injury in cs group.3.11 patients had endplate injury in ncs group.

Manufacturer Narrative

Zhao xie, zeng long tianhang xiandi wang, zhiqiang yang, xingxiao pu, yufei lu and jiancheng: clinical and radiological evaluation of cage subsidence following oblique lumbar interbody fusion combined with anterolateral fixation.Https://doi.Org/10.1186/s12891-022-05165 a2: mean age of 66 years (range 55 to 77 years).This value is the average age of the patients reported in the article as specific patients could not be identified.A3: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.B3: date that the article was published online as the event dates were not provided in the published literature.D4: product identifiers are unknown.H6: 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.G3: 510(k)# is unknown.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: CLYDESDALE SPINAL SYSTEM
• 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: 15585403
• MDR Text Key: 301548054
• Report Number: 1030489-2022-00941
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_CLYD_IMP
• Device Catalogue Number: MSB_UNK_CLYD_IMP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/12/2022
• 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 Age: 66 YR
• Patient Sex: Female