MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCT : TELEFIX; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Device Problem Device Slipped (1584)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown arcofix/telefix/ventrofix implants: telefix/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.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.

Event Description

Device report from synthes reports an event in switzerland as follows: this report is being filed after the review of the following journal article: scheufler h.M., (2007) :technique and clinical results of minimally invasive reconstruction and stabilization of the thoracic and thoracolumbar spine with expandable cages and ventrolateral plate fixation, neurosurgery volume 61, number 4, pages 798-809 (switzerland).This study aims to report specific technical modifications and clinical results of thoracic and thoracolumbar vertebral body replacement (vbr) with expandable cages and ventrolateral plate fixation (vpf) of via minimally invasive anterolateral retropleural (alra) or combined extracoelomic thoracoabdominal approaches (cleta).Between february 2004 and may 2006, 38 patients (22 men, 16 women; age range, 34¿85 yr; mean age, 64.1 yr) presenting with either disabling back pain and/or progressive neurological deficits due to spinal cord or nerve root compression from spinal metastasis (n _ 28), spinal fractures (n _ 5) or spondylitis (n _ 5) were treated by single- or multilevel corpectomy, spinal canal decompression, and anterior column reconstruction using expandable vbr devices and vpf via minimally- invasive alra or cletaapproaches, respectively.During surgery, a table-mounted frame retractor system (synframe; stratec medical, oberdorf, switzerland) was introduced sequentially to retract the lung from the lateral surface of the spinal column.Spinal reconstruction was completed by ventrolateral plate fixation (telefix; stratec medical, or vantage; medtronic sofamor danek, memphis, tn).The remainder of the wound was closed in layers.The skin was either sutured or sealed with cyanoacrylate (dermabond; ethicon, norderstedt, germany) and dressed.The mean follow-up period was 22.8 months (range, 11¿37 mo).The following complications were reported as follows: one patient (patient 20) died 4 months after index surgery as a result of significant medical comorbidity (ischemic cardiac myopathy).15 did not achieve fusion.Bony fusion was confirmed by lateral x-rays or multiplanar ct scans in all but the two most recent patients (duration of follow-up, 11 and 13 mo.) loss of correction of sagittal deformity (0.9 degrees), an elderly osteopenic female patient (patient 37) was readmitted 3 months after index surgery due to recurrent back pain.Loosening of the ventrolateral plate construct was confirmed by ct scans.She was successfully treated by removal of the lateral plate, augmentation of the flanking vertebrae with bone cement, repositioning of the cage and additional percutaneous posterior pedicle screw fixation.Postoperative karnofsky indices improved significantly in all but one patient (patient 18).One patient (patient 22) presenting with significant preoperative intercostal neuralgia reported postoperative persistence of symptoms and was treated with serial intercostal analgesic blocks.This report is for an unknown synthes ventrolateral plate fixation (telefix).This is report 2 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCT : TELEFIX
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14135982
• MDR Text Key: 289451353
• Report Number: 8030965-2022-02496
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2022
• 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