MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN VERTEBRAL BODY REPLACEMENT - MESH; SURGICAL MESH

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown vertebral body replacement - mesh/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: nader r et al (2002), preoperative embolization and intraoperative cryocoagulation as adjuncts in resection of hypervascular lesions of the thoracolumbar spine, j neurosurg (spine 3), volume 97, page 294-300, (usa).The purpose of this study was twofold.First, the authors evaluated preoperative embolization alone to reduce estimated blood loss (ebl) when resecting hypervascular lesions of the thoracolumbar spine.Second, they compared this experience with intraoperative cryotherapy alone or in conjunction with embolization to minimize further ebl.Between 1995 and 1997, 12 patients (nine men and three women, mean age 58 years [range 37¿77 years]) who underwent 13 surgeries for hypervascular spinal tumors were included in the study.In 10 patients, the surgeries were augmented by preoperative embolization alone.In 1 patient, 2 different surgeries involved intraoperative cryocoagulation, and in 1 patient surgery involved a combination of preoperative embolization and intraoperative cryocoagulation for tumor resection.All 12 patients underwent corpectomy, and additional laminectomy was performed in 8.Spinal stabilization was augmented by the placement of anterior instrumentation.Unknown depuy spine harms cages filled with autologous bone grafts or allografts were implanted in 11 patients.Spinal stabilization was established using the unknown depuy spine kaneda (depuy acromed, raynham, ma) device in 11 patients.The unknown depuy spine moss¿miami (depuy acromed, raynham, ma) system was placed in 2 patients whom laminectomy was required and posterior instrumentation supplemented stabilization.The mean follow-up period was 14.7 months (range 6 months¿5 years).The article did not specify which of these patients were implanted with the depuy spine devices.Thus, complications will be reported as follows: unknown patient had an intraoperative t-11 rib fracture.Unknown 3 patients underwent postoperative spinal radiotherapy.Case 3, a (b)(6)-year-old male had excessive bleeding interfering with operation.The estimated blood loss was 4000 ml.Case 4, a (b)(6)-year-old male suffered deterioration of his paraparesis and developed transient paraplegia, with partial recovery.Case 5, a (b)(6)-year-old male had massive bleeding interfering with excision.The estimated blood loss was 8000 ml.Postoperatively, the patient had an enterococcal wound infection and paraspinal abscess.He was treated by ct-guided drainage and intravenous antibiotic therapy to which he responded well.Case 9, a (b)(6)-year-old female who had pleural effusions and pneumothorax.She subsequently underwent radiotherapy.Case 12, a (b)(6)-year-old male had a new metastasis¿ induced t-6 wedge compression that was revealed during the 6-month follow-up examination.A second surgery was then performed at 1 year postoperatively.This report is for the unknown vertebral body replacement - mesh.It captures the events for the reported (b)(6)-year-old male with new metastasis and underwent second surgery.This is report 4 of 6 for complaint (b)(4).This complaint involves a total of 18 impacted products.Additional devices are captured under linked complaint (b)(4).

• Brand Name: UNKNOWN VERTEBRAL BODY REPLACEMENT - MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9525876
• MDR Text Key: 189162822
• Report Number: 1526439-2019-52798
• Device Sequence Number: 1
• Product Code: EZX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR